Hip Stem Instrument Set — Cemented and Cementless Femoral Workflow

Hip Stem Instruments Set, SKU PS-OP-5568, is a 57-component reusable German stainless steel system for femoral preparation, stem implantation, head trialing, and bipolar hemiarthroplasty. It includes a head impactor, measurement device, five 28 mm head trials from −3 to +8 mm, femoral head extractor, head extractor, bipolar ring forceps, cup impactor, four initial femoral drills, T-handle, rod, connection part, cement plug impactor, hammer, rasp handle, stem impactor, offset template, trochanteric rasp, and chisel. Six cemented stem rasps cover 7–12 mm, while seven additional calibrated components span 7.5–13.5 mm. Nine bipolar head trials cover 42–58 mm, and ten cement plug trials span 9–18 mm. Container 9702-000 organizes the set. Orthopedic arthroplasty and trauma surgeons use this instrumentation during cemented or system-compatible cementless total hip arthroplasty, bipolar hemiarthroplasty for displaced femoral-neck fractures, and selected femoral revision procedures. The system supports canal entry, progressive preparation, trial reduction, cement restrictor selection, definitive stem seating, head assembly, and component extraction in hospital operating rooms and specialist joint-reconstruction centers.

Drilling, Broaching, Couplings, and Impaction Control

Initial femoral drills 9702-0011 through 9702-0014 establish the canal axis and progressively prepare diameters of 7.5/8.5, 9/10, 11/12, and 13.5 mm. The T-handle provides rotational leverage, while the rod and connection part couple compatible modular instruments within the preparation sequence. Rasp handle 9702-0020 locks onto the selected broach and transfers axial impaction, extraction force, anteversion control, and coronal alignment. Cemented stem rasps from 7 through 12 mm create progressively larger stem-shaped envelopes while preserving space required by the corresponding cemented technique. The trochanteric rasp removes obstructing proximal lateral bone that could deflect the stem into varus. Chisel 9702-0024 opens or releases localized proximal bone and interface material. Hammer 9702-0019 supplies controlled impact force. Stem impactor 9702-0021 transfers that force to the definitive femoral component without striking the implant directly. Head impactor 9702-0001 seats the selected head onto the compatible taper after the junction has been cleaned and dried. Every coupling must be fully engaged before drilling, rasping, extraction, or impaction begins.

Cemented Stem and Bipolar Hemiarthroplasty Workflow

After femoral-head extraction and neck resection, the canal is opened along the proximal femoral axis. Initial drills establish the pathway before progressive rasps prepare the planned stem envelope and provide tactile information regarding depth, version, cancellous engagement, and cortical proximity. For cemented fixation, the surgeon selects a plug using trials from 9 to 18 mm. Cement plug impactor 9702-0018 advances the chosen restrictor to the planned depth so the cement column can be contained distal to the stem. The definitive component is introduced after canal cleaning, drying, cement delivery, and pressurization, then seated with the stem impactor. Offset template 9702-0022 and 28 mm head trials evaluate limb length, femoral offset, soft-tissue tension, stability, and impingement before final assembly. During bipolar hemiarthroplasty, trials from 42 to 58 mm assess correspondence with the native acetabulum. Bipolar ring forceps control the shell during handling and assembly, while the cup impactor seats the compatible bipolar component. Femoral head extractor and head extractor support disassembly during head exchange or revision. The measurement device supplies the system-specific dimensional reference used during implant selection.

Rasp, Head Trial, and Cement Plug Size Selection

Cemented hip stem rasps progress from 7 to 12 mm in 1 mm increments and must correspond with the selected prosthesis system and required cement mantle. The additional calibrated series covers 7.5, 8.5, 9, 10, 11, 12, and 13.5 mm, providing a second diameter sequence within the 9702 system. Selection depends on preoperative templating, canal morphology, implant design, cortical thickness, rasp stability, and fixation method. Head trials use a constant 28 mm articulation with −3, neutral, +4, +6, and +8 mm neck-length options. The −3 mm version shortens the reconstructed neck relative to neutral, while positive options progressively increase length and offset according to the system geometry. Bipolar trials from 42 through 58 mm advance in 2 mm increments and assess external shell fit against the retained acetabulum. Cement plug trials span 9–18 mm in 1 mm steps and are selected for circumferential canal engagement at the intended distal level. Head, shell, rasp, and restrictor sizes perform separate functions and are not interchangeable measurement systems. The final choice follows trial findings and the compatible implant technique.

German Stainless Steel, Reprocessing, and Documentation

German stainless steel provides the rigidity, corrosion resistance, and dimensional stability required for drilling, broaching, extraction, and repeated impaction. Cutting instruments require inspection for retained bone, dull teeth, chipping, bending, or eccentric wear. Drills must rotate concentrically without damaged flutes, and modular connections must seat without looseness. The hammer, stem impactor, head impactor, cement plug instrument, extractors, forceps, templates, and trials require examination for deformation, cracking, damaged interfaces, or unreadable size markings. Components should be disassembled where their validated design permits so cleaning reaches recesses, threads, teeth, and connection surfaces. The system must be cleaned, rinsed, inspected, dried, packaged, and steam sterilized according to institutional validation and manufacturer instructions. CE documentation concerns conformity with applicable European medical-device requirements. ISO 13485 addresses the quality management system governing manufacture and traceability. FDA procurement depends on the establishment, listing, labeling, importer, and destination-market records. Container 9702-000 supports organization and counting but does not independently establish cleaning efficacy, sterilization parameters, drying, or sterile shelf life.

Products Specifications

How does this set differ from the Total Hip Prosthesis Instruments Set 9713?
Hip Stem Instruments Set concentrates on the femoral side of hip reconstruction. Set 9713 focuses on acetabular reaming, cup trialing, shell orientation, screw fixation, and liner seating. The 9702 system contains initial femoral drills, stem rasps, cement plug instruments, stem impactors, head trials, and bipolar shell trials. Those components prepare and reconstruct the proximal femur rather than the acetabular cavity. A complete total hip arthroplasty workflow can require both systems when their components match the selected implant family. Bipolar hemiarthroplasty ordinarily uses the femoral and bipolar functions without acetabular cup implantation.

How are the rasp, bipolar head, and cement plug sizes selected?
Hip Stem Instruments Set provides separate sizing sequences for distinct operative functions. Stem rasps are selected through radiographic templating, progressive preparation, cortical resistance, implant geometry, and fixation method. Bipolar trials from 42 to 58 mm assess external shell correspondence with the retained native acetabulum. Cement plug trials from 9 to 18 mm identify circumferential canal engagement at the planned restrictor depth. The 28 mm head trials adjust neck length and offset after stem preparation. A measurement from one sequence cannot be transferred directly to another. Final selection must follow the compatible implant system and its operative technique.

What do CE, ISO 13485, and FDA references mean for procurement?
CE documentation concerns conformity with applicable European medical-device requirements. ISO 13485 addresses the quality management system governing manufacturing and traceability. Neither designation independently means that Hip Stem Instruments Set has received FDA approval. United States procurement requires the relevant establishment, listing, labeling, importer, and market-access documentation. Hospitals should retain these records with the SKU, full component table, maintenance history, and supplier information. The documentation supports vendor qualification, inventory control, instrument traceability, and complaint handling.

How do the handles and impactors control femoral preparation?
The T-handle provides rotational leverage for compatible initial preparation instruments. The rasp handle locks onto the selected broach and controls advancement, extraction, version, and coronal orientation. The connection part and rod transmit force between compatible modular components. Hip Stem Instruments Set includes a separate stem impactor for definitive femoral component seating and a head impactor for taper assembly. The cement plug impactor controls distal restrictor placement in cemented fixation. Every connection must be fully seated, aligned, and functionally tested before force is applied.

How should the complete set and aluminum container be reprocessed?
All components should be counted and transferred for decontamination immediately after surgery. Drills, rasp teeth, plug trials, head trials, forceps, extractors, impactors, and coupling recesses require direct cleaning and inspection. Hip Stem Instruments Set should be disassembled where its validated design permits. Instruments must then be rinsed, dried, functionally tested, packaged, and steam sterilized according to institutional and manufacturer instructions. The aluminum container organizes the inventory but does not independently establish sterilization efficacy. The tray should be released only after count reconciliation, cycle completion, drying, packaging inspection, and sterilization-record approval.