Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3000](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3000) → JDT — Cap, Bone

# JDT · Cap, Bone

_Orthopedic · 21 CFR 888.3000 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDT

## Overview

- **Product Code:** JDT
- **Device Name:** Cap, Bone
- **Regulation:** [21 CFR 888.3000](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3000)
- **Device Class:** 1
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## Identification

A bone cap is a mushroom-shaped device intended to be implanted made of either silicone elastomer or ultra-high molecular weight polyethylene. It is used to cover the severed end of a long bone, such as the humerus or tibia, to control bone overgrowth in juvenile amputees.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDT](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDT)

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