Large Fragment Plates Set for 4.5 mm Compression and Buttress Fixation

Large Fragment Plates Set, SKU PS-OP-4648, is a 40-implant orthopedic fixation assortment made from German stainless steel. The configuration comprises one Semi-Tubular Plate 4.5 in each 4-, 5-, 6-, and 7-hole length; two Narrow Dynamic Compression Plates 4.5 in each 5-, 6-, 7-, 8-, 9-, and 10-hole length; two Broad Dynamic Compression Plates 4.5 in each 6-, 7-, and 8-hole length plus one in each 9-, 10-, 11-, 12-, 14-, and 16-hole length; one T-Plate 4.5 and one T-Buttress Plate 4.5 in each 4-, 5-, 6-, 7-, and 8-hole shaft length; one right/left-angled L-Buttress Plate 4.5 with four holes; one left/right-angled counterpart with four holes; and container 900.042. The set supports open reduction and internal fixation of simple transverse or short-oblique tibial, femoral, and humeral shaft fractures, neutralization after lag-screw compression, and buttress fixation of proximal tibial metaphyseal or plateau split patterns. It is intended for orthopedic trauma surgeons working in hospital operating rooms, trauma centers, and specialist fracture units where implant choice follows fracture morphology, bone dimensions, surgical approach, and preoperative imaging.

Compression-Hole Geometry and Buttress Mechanics

The straight dynamic compression profiles convert screw insertion into controlled plate translation. Each oval hole incorporates an inclined surface; when a conventional cortex screw is placed eccentrically on the load side and tightened, its head travels down that slope, shifts the implant longitudinally, and draws the reduced fragments together. Central placement in the same opening functions in neutral mode after compression has been established. Narrow bodies reduce transverse footprint on the tibial or humeral shaft, whereas broad bodies increase contact width for the femoral cortex and higher-load constructs. Semi-tubular geometry provides a lower-profile, readily contourable option for a limited bony surface where a full-width member is unnecessary. The transverse head of the T form distributes fixation across a metaphyseal segment while its longitudinal stem anchors into the diaphysis. T-buttress and mirrored L-buttress shapes oppose shear at a split or periarticular fragment; their head geometry captures the epiphyseal or metaphyseal block while the shaft resists distal displacement. Right/left and left/right angulation permits side-specific placement around the proximal tibia. Plate benders are used outside the body to match cortical contour without deforming screw recesses, and final stability depends on reduction quality, hole position, screw trajectory, and adequate purchase on both sides of the fracture.

Fracture Fixation Workflow by Anatomical Site

For tibial or humeral diaphyseal ORIF, the surgeon restores length, axis, and rotation, holds the simple fracture with reduction forceps, then selects a narrow 4.5 configuration long enough to secure the proximal and distal main fragments. A transverse pattern can receive eccentric load screws to generate axial compression; a short-oblique pattern can first receive an interfragmentary lag screw, followed by neutralization plating. Broad profiles are selected for femoral shaft exposure when the larger cortical surface and mechanical environment require a wider construct. The chosen member is contoured, centered across the fracture, provisionally held, drilled through a guide, depth measured, tapped when required, and secured while compression and alignment are monitored fluoroscopically. At the proximal tibia, joint-surface reduction precedes definitive fixation. Subchondral wires or lag screws maintain a plateau split, after which a T-buttress or side-specific L-buttress form is seated against the metaphysis to counter axial and shear displacement. The T-Plate provides a transverse cluster for a broader metaphyseal segment, while semi-tubular models address smaller cortical zones within the large-fragment workflow. Final anteroposterior and lateral imaging checks implant position, screw length, articular clearance, mechanical alignment, and stability before irrigation and closure.

Hole Counts, Profiles, and Selection Rationale

The four Semi-Tubular 4.5 options span 4, 5, 6, and 7 holes, allowing a short contourable construct to be matched to the available cortical segment. Narrow DCP models cover 5 through 10 openings, with two of every length; shorter members suit compact diaphyseal exposure, while 9- and 10-hole versions provide greater working length around a tibial or humeral shaft fracture. Broad DCP inventory includes two each at 6, 7, and 8 holes for frequently used femoral configurations, then one each at 9, 10, 11, 12, 14, and 16 holes for progressively longer fracture zones or wider screw distribution. Five T-Plates carry 4, 5, 6, 7, or 8 shaft holes, pairing metaphyseal head fixation with a selected diaphyseal span. Five T-Buttress counterparts use the same stem range when resistance to metaphyseal shear is the primary requirement. The four-hole right/left-angled L profile and four-hole left/right-angled L profile provide mirrored orientation for the relevant side and column of the proximal tibia. Selection is based on fracture line, comminution, plate position, planned screw density, and the amount of intact bone available beyond the injury. The perforated 900.042 container separates each configuration for counting, transport, decontamination, and sterile presentation.

German Stainless Steel, Reprocessing, and Procurement Controls

German stainless steel gives these fixation plates the rigidity needed to transmit contouring, screw seating, axial compression, and buttress loads while providing corrosion resistance through cleaning and steam exposure. The smooth polished implant surface limits rough interfaces against soft tissue and facilitates visual inspection for scratches, bending damage, residue, or corrosion before the item enters the sterile field. This assortment is supplied as a non-sterile implant system and must undergo cleaning, packaging, and steam sterilization through the healthcare facility’s validated cycle and the supplied device instructions before implantation. Plates removed from packaging for processing remain single-use implants once placed in a patient; they are not reprocessed for another implantation. The perforated container permits detergent and rinse contact, drying, and sterilant circulation, while organized positions support count reconciliation. CE marking addresses conformity with the applicable European medical-device framework, and ISO 13485 identifies the quality-management system governing controlled manufacture and supply. For United States purchasing, FDA context concerns the applicable establishment registration, device listing, labeling, importer, and premarket documentation rather than a blanket certification claim. Procurement teams should retain the declaration of conformity, ISO certificate, lot traceability, device labeling, instructions for use, and shipment records within the facility’s implant-control file.

Products Specification

How does this set differ from a locking compression plate system?
The Large Fragment Plates Set uses conventional 4.5 dynamic compression and buttress profiles whose screws draw the plate toward the cortex. A locking compression plate accepts threaded locking heads that engage the plate hole and create a fixed-angle construct. Conventional DCP holes can generate axial compression through eccentric screw placement, whereas a locking screw seated in its threaded opening does not create that translation. The broad and narrow members in this assortment depend on plate-to-bone contact, contour, and bicortical screw purchase for stability. A locking construct can preserve more periosteal clearance and is often considered for osteoporotic bone, comminution, or bridge techniques. Selection rests on fracture morphology, bone quality, reduction strategy, available soft-tissue envelope, and the surgeon’s planned screw configuration.

How should the hole count and plate profile be selected?
The Large Fragment Plates Set provides profile and length choices for the intact bone available on each side of the fracture. Narrow 5- to 10-hole DCP models fit the smaller transverse footprint of the tibial or humeral shaft, with longer versions used when the fracture zone requires greater working length. Broad 6- to 16-hole choices address the femoral shaft or another large cortical surface where a wider body and expanded screw distribution are planned. Semi-tubular 4- to 7-hole pieces suit short, contourable fixation on a limited surface. T and T-buttress stems are selected from 4 through 8 holes according to the distance from the proximal tibial metaphysis into intact diaphysis. The mirrored four-hole L-buttress profiles are oriented to the involved side and plateau column after CT and fluoroscopic planning.

What do CE, ISO 13485, and FDA terms mean for procurement?
The Large Fragment Plates Set is presented for CE-marked and ISO 13485-controlled procurement. CE marking indicates the manufacturer’s declaration that the device meets the applicable European legal requirements and is supported by conformity documentation. ISO 13485 concerns the medical-device quality-management system used for controlled production and supply; it is not a clinical outcome guarantee. United States buyers evaluate the applicable FDA pathway, establishment registration, device listing, labeling, and importer records for the supplied configuration. FDA registration or listing alone does not denote approval, clearance, or authorization. A hospital or distributor file should include the current declaration of conformity, ISO certificate scope, UDI or lot data, labeling, instructions for use, and jurisdiction-specific market documentation.

How does the dynamic compression hole control fracture compression?
The inclined oval hole is the principal control feature in the Large Fragment Plates Set. After anatomic reduction and provisional fixation, the drill guide positions a cortex screw eccentrically on the load side of the opening. Tightening makes the screw head descend the slope and translate the plate relative to bone. That movement draws the mobile main fragment toward the opposite segment and compresses the fracture line. Once compression is established, additional screws can be centered in neutral mode to maintain fixation without repeating the translation. The surgeon monitors reduction, opposite-cortex contact, plate position, and screw trajectory because incorrect eccentric direction or unstable provisional control can displace the fracture.

What should an operating-room procurement team check before sterilization?
The Large Fragment Plates Set should be reconciled against the 40-plate configuration and container 900.042 on receipt. Staff should inspect each surface, dynamic hole, T head, L profile, and tray position for transport damage, residue, corrosion, or unintended deformation. Lot identification, labeling, instructions for use, conformity records, and purchase documentation should remain linked to the delivered batch. Because the implants are supplied non-sterile, the facility applies its validated cleaning, packaging, steam cycle, drying, and release process before surgery. The perforated tray supports fluid contact and sterilant circulation but does not replace validated load configuration or local sterile-processing controls. Any implanted item is single-use, while unused stock remains managed according to its labeling, traceability rules, and institutional implant policy.