---
kind: "section"
citation: "21 C.F.R. § 888.4505"
title: "21"
number: "888.4505"
heading: "Orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation."
url: "https://uscodex.org/cfr/21/888.4505"
---

# §888.4505. Orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation.

- (a) **Identification.** Orthopedic surgical instruments designed for osteochondral implants with press-fit fixation are hand-held devices intended to manipulate bone and cartilage tissue or the implant for the positioning, alignment, defect creation, and placement of press-fit osteochondral implants that utilize no additional means of fixation (e.g., suture fixation, adhesives). This type of device includes instruments specific to the geometry of the implant.
- (b) **Classification.** Class II (special controls). The device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 888.9](/cfr/21/888.9.md). 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 and place the implant.
  - (2) The patient contacting components of the device must be demonstrated to be biocompatible.
  - (3) 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

[84 FR 57321, Oct. 25, 2019, as amended at 85 FR 44188, July 22, 2020]

### 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

[84 FR 57321, Oct. 25, 2019, as amended at 85 FR 44188, July 22, 2020]