---
kind: "section"
citation: "21 C.F.R. § 888.4515"
title: "21"
number: "888.4515"
heading: "Orthopedic manual surgical instrumentation for use with total disc replacement devices."
url: "https://uscodex.org/cfr/21/888.4515"
---

# §888.4515. Orthopedic manual surgical instrumentation for use with total disc replacement devices.

- (a) **Identification.** Orthopedic manual surgical instrumentation for use with total disc replacement devices are non-powered hand-held devices designed specifically for use with a total disc replacement device and interface with the associated implant for the purpose of insertion, removal, placement, or repositioning, or to cut, rasp, or create a defect specific to the features of the associated implant. This type of device includes instruments specific to the geometry of the implant.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Technical specifications regarding geometry of the instruments must be specified and validated to demonstrate that the instruments can safely position, place, or remove the implant.
  - (2) The patient contacting components of the device must be demonstrated to be biocompatible.
  - (3) Performance data must demonstrate that reprocessing of reusable devices that are provided non-sterile, or sterilization of devices provided sterile, is validated.
  - (4) Labeling must include:
    - (i) Identification of implant(s) and instruments which have been validated for use together; and
    - (ii) **Validated methods and instructions for reprocessing any reusable parts.**

## Notes

### Amendments

[90 FR 40734, Aug. 21, 2025]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.

### Source

Source: 52 FR 33702, Sept. 4, 1987, unless otherwise noted.

### Amendments

[90 FR 40734, Aug. 21, 2025]