---
kind: "section"
citation: "21 C.F.R. § 888.3630"
title: "21"
number: "888.3630"
heading: "Resorbable shoulder spacer."
url: "https://uscodex.org/cfr/21/888.3630"
---

# §888.3630. Resorbable shoulder spacer.

- (a) **Identification.** A resorbable shoulder spacer is intended to act as a temporary spacer, creating a physical barrier between tissues in the shoulder, for the treatment of massive irreparable rotator cuff tears.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following:
    - (i) Evaluation of improvement of shoulder function and reduction of symptoms (e.g., pain and function) for the indications for use; and
    - (ii) **Evaluation of relevant adverse events.**
  - (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following:
    - (i) Integrity testing of the device, including mechanical and chemical stability; and
    - (ii) **Characterization of the device degradation profile.**
  - (3) Animal performance testing must include evaluation of the following:
    - (i) Adverse effects, including gross necropsy and histopathology; and
    - (ii) **Device degradation to verify in vitro versus in vivo degradation correlation.**
  - (4) All patient-contacting components of the device must be demonstrated to be biocompatible.
  - (5) Performance data must support the sterility and pyrogenicity of the device components intended to be sterile.
  - (6) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
  - (7) Labeling must include the following:
    - (i) Instruction for use, including specific instructions regarding device selection and placement;
    - (ii) A detailed summary of the clinical performance testing with the device, including procedure- and device-related complications or adverse events; and
    - (iii) **A shelf life.**

## Notes

### Amendments

[87 FR 981, Jan. 6, 2023]

### 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

[87 FR 981, Jan. 6, 2023]