Zero-P Spacers Complete Set – 36-Piece Cervical Implant and Instrument System for ACDF

The Zero-P Spacers Complete Set with Cervical Implant and Instrument System from Peak Surgicals is a fully integrated 36-piece anterior cervical spine system combining zero-profile anterolateral fixation spacers with the complete dedicated instrument set required to perform anterior cervical discectomy and fusion (ACDF) using the zero-profile technique — including cage trials in 8 heights (5–12mm), all insertion and fixation instruments, drill bits, an AWL, a calibrated torque wrench, and a dual-tray aluminium storage system. It is used by spine surgeons and neurosurgeons in hospital operating theatres performing cervical ACDF for disc herniation, cervical spondylosis, and cervical instability requiring anterior interbody fusion.

Zero-Profile Anterolateral Fixation: ACDF Without an Anterior Cervical Plate

Conventional anterior cervical discectomy and fusion uses a separate interbody cage and an anterior cervical plate fixed to the vertebral body surfaces with screws. The anterior plate provides construct stability but extends its profile onto the esophageal surface of the cervical spine, where it remains in contact with the posterior esophageal wall and contributes to postoperative dysphagia — one of the most common complications of anterior cervical surgery. Zero-profile spacer systems address this by integrating the fixation function into the cage itself. The spacer incorporates anterolateral screw channels through which fixation screws are inserted from within the disc space directly into the adjacent vertebral bodies, providing plate-equivalent fixation without any implant profile on the anterior vertebral surface. The result is a stable interbody construct with reduced anterior soft tissue irritation and, in clinical studies, a lower rate of postoperative dysphagia compared to anterior plated ACDF.

Complete Instrument Set: All 36 Components Listed

The Zero-P Spacers Complete Set provides every instrument needed for the zero-profile ACDF workflow in a single tray system. The full component list is as follows: AWL Curved (2200-1601) for initial disc space access; Pin Holder (2200-1602) for pin management; Open Drill Straight with Sleeve (2200-1603) for screw trajectory preparation; Impact Device (2200-1604) for cage seating; Cage Holder (2200-1605) for implant handling; Screw Caddy (2200-1606) for screw organisation; Retractor (2200-1607) for surgical field exposure; Compactor (2200-1608) for endplate preparation; Pins x2 (2200-1609) for retractor fixation; Torx Screwdriver (2200-1610) for anterolateral fixation screws; Drill Bit 12mm (2200-1611), Drill Bit 14mm (2200-1612), and Drill Bit 16mm (2200-1613) for screw trajectory drilling; Nedical Tweezer (2200-1614); Cage Trials in 5mm (2200-1615), 6mm (2200-1616), 7mm (2200-1617), 8mm (2200-1618), 9mm (2200-1619), 10mm (2200-1620), 11mm (2200-1621), and 12mm (2200-1622) for intraoperative height trialling; 1.2 N.m Torque Wrench (2200-1623) for calibrated screw tightening; Poaxial Screwdriver (2200-1624); Holding Forcep (2200-1625); Sleeve (2200-1626); Pusher Round (2200-1627); Sleeve (2200-1628); Pusher Flat (2200-1629); Straight Handle (2200-1630); Straight Handle (2200-1631); Compactor Box (2200-1632); Drill Guider (2200-1633); Screw Sleeve (2200-1634); Large Straight Handle (2200-1635); and Aluminium Box (2200-1636).

Cage Trials 5–12mm and Calibrated Torque Fixation

The eight cage trial sizes (5mm through 12mm, reference 2200-1615 through 2200-1622) allow the surgeon to sequentially insert trial spacers into the prepared disc space after discectomy and endplate preparation to confirm the correct cage height before the definitive implant is placed. Selecting the appropriate cage height is critical in zero-profile ACDF — an undersized cage fails to restore disc height and foraminal height, leaving the decompression incomplete, while an oversized cage risks endplate fracture and subsidence. The 1.2 N.m Torque Wrench (2200-1623) provides calibrated screw tightening to the specified torque for the anterolateral fixation screws, ensuring consistent screw seating across all levels without the risk of overtightening that can strip the screw-vertebral bone interface or undertightening that leaves the construct insufficiently stable for immediate postoperative mobilization.

Dual-Tray Aluminium Box Organization for Theatre Efficiency

All 36 components are organized in dedicated slots across a dual-tray aluminium box (2200-1636), with implant holders and instrument holders arranged to allow immediate visual identification and access to each component during the procedure. The dual-tray configuration separates cage trials from instruments, reducing instrument table clutter during the critical intraoperative phase when the surgeon needs to trial spacer heights sequentially without delay. The perforated trays are compatible with standard autoclave sterilization protocols, and the aluminium box provides rigid protection for all components during theatre transport, storage between cases, and sterilization cycle processing.

CE Mark, ISO 13485, and FDA Certification for Spine Surgery Procurement

The Zero-P Spacers Complete Set is manufactured under CE Mark, ISO 13485, and FDA compliant quality standards. ISO 13485 certification confirms Peak Surgicals operates a documented quality management system covering design control, material traceability, and production consistency for surgical instruments and implant systems. CE Mark confirms conformity with European medical device regulations, and FDA compliance supports procurement for US-based hospitals, spine surgery centres, and neurosurgical departments requiring verified regulatory documentation for capital instrument and implant set purchases.

Product Specifications

Frequently Asked Questions

What is included in the Zero-P Spacers Complete Set and how is it organised?
The Zero-P Spacers Complete Set contains 36 pieces — all the instruments and cage trials required for zero-profile ACDF — organised in a dual-tray aluminium box. The instrument tray contains the AWL Curved, Pin Holder, Open Drill with Sleeve, Impact Device, Cage Holder, Screw Caddy, Retractor, Compactor, Pins, Torx Screwdriver, three drill bits (12/14/16mm), Torque Wrench, Poaxial Screwdriver, Holding Forcep, Sleeves, Pushers, Straight Handles, Compactor Box, Drill Guider, and Screw Sleeve. The implant tray contains eight cage trials from 5mm to 12mm in 1mm increments. The dual-tray organisation separates cage trials from instruments so both categories are immediately accessible during the procedure without requiring the surgeon to search through a single instrument pile.

How does this Complete Set differ from the Zero-P Spacers 35pcs Set also available from Peak Surgicals?
Both sets are zero-profile cervical ACDF spacer systems in the same product family, but they differ in content and configuration. The Zero-P Spacers Complete Set has a confirmed full instrument list with 36 named components across reference numbers 2200-1601 to 2200-1636, including a calibrated 1.2 N.m Torque Wrench and a dual-tray aluminium storage system — this is the comprehensive single-source instrument set with every component needed for the procedure. The Zero-P Spacers 35pcs Set (35 pieces, $3,298.90) is configured around a broader spacer implant matrix across multiple height and lordotic angle combinations, making it the set for programmes that need wider spacer coverage across different angle configurations. The Complete Set is the primary choice for programmes establishing a zero-profile ACDF instrument and cage trial system from scratch.

Why does the set include three drill bit lengths (12mm, 14mm, 16mm)?
The three drill bit lengths correspond to different vertebral body depths encountered at cervical levels — shorter vertebral bodies at upper cervical levels and longer bodies at lower cervical levels. The screw trajectory for anterolateral fixation passes from the spacer at an angle into the adjacent vertebral body, and the depth of the trajectory varies depending on the cervical level, the size of the vertebral body, and the planned screw length. Providing 12mm, 14mm, and 16mm drill bits in the set ensures that the surgeon can prepare the screw trajectory to the appropriate depth for the screw length being used, without risk of over-drilling into adjacent structures.

What is the purpose of the calibrated 1.2 N.m Torque Wrench?
The 1.2 N.m Torque Wrench (2200-1623) allows the anterolateral fixation screws of the zero-profile spacer to be tightened to a specified torque rather than by feel. In cervical spine surgery, the small diameter of the fixation screws and the limited bone density of cervical vertebral bodies mean that overtightening by even a small margin can strip the screw thread in bone and compromise fixation, while undertightening leaves the construct without the compressive stability needed for fusion and immediate mobilization. A calibrated torque wrench standardises this step across different surgeons and cases, reducing the variability in fixation quality that occurs with manual tightening by feel.

What certifications does this set carry?
The Zero-P Spacers Complete Set is manufactured under CE Mark, ISO 13485, and FDA compliant quality standards. ISO 13485 certification confirms Peak Surgicals operates a documented quality management system covering design control, material traceability, and manufacturing consistency for surgical instruments and implant systems. CE Mark confirms conformity with European medical device regulations, and FDA compliance supports procurement for US hospitals, spine surgery centres, and neurosurgical departments requiring verified regulatory documentation.

Can individual instruments be ordered as replacements?
Individual instruments from the Zero-P Spacers Complete Set are available from Peak Surgicals as replacement items using their 2200-series reference numbers (e.g., 2200-1623 Torque Wrench, 2200-1605 Cage Holder, individual cage trial sizes). OEM manufacturing and custom configurations are also available for hospital procurement departments and spine surgery distributors requiring modified tray layouts, extended cage trial size ranges, or custom packaging. Contact Peak Surgicals directly for replacement instrument pricing, OEM specifications, or institutional procurement arrangements.