# 2026-13101: FDA Approves Shock Absorber You Can Actually Implant in Your Knee

2026-13101, Medical Devices; Orthopedic Devices; Classification of the Medial Knee Implanted Shock Absorber, is a Federal Register rule from Health and Human Services Department, Food and Drug Administration published 2026-06-29, effective 2026-06-29; PRIA reads it as touching household money (as of 2026-07-06).

- Canonical: https://policyrisk.com/federal-register/2026-13101
- As of: 2026-07-06
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-13101
- Title: Medical Devices; Orthopedic Devices; Classification of the Medial Knee Implanted Shock Absorber
- Type: Rule
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 39007
- Published: 2026-06-29
- Effective: 2026-06-29
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-07-06

## In one line

FDA Approves Shock Absorber You Can Actually Implant in Your Knee

## Summary

The FDA is officially classifying the medial knee implanted shock absorber as a Class II device, meaning it has special safety rules but fewer hurdles than the strictest category. This change helps patients get access to this innovative knee device faster and with confidence in its safety. The new classification is effective June 29, 2026, and could save time and money for makers and users alike.

## Abstract

The Food and Drug Administration (FDA) is classifying the medial knee implanted shock absorber into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the medial knee implanted shock absorber. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

## Effects PRIA read

- Medial Knee Shock Absorber Now Class II: benefit, medium. The FDA classified the medial knee implanted shock absorber as a Class II device with special controls, effective June 29, 2026 (classification applicable April 10, 2023). FDA says this reduces regulatory burdens and is intended to enhance patient access and speed availability of this knee implant.
- Manufacturers Must Use 510(k) Pathway: benefit, medium. The medial knee implanted shock absorber is subject to premarket notification under section 510(k), meaning device sponsors must submit a 510(k) to market this Class II device unless FDA later exempts it. FDA also notes a De Novo-classified device can serve as a predicate for future 510(k) submissi…
- Required Testing, Training, and Labeling Controls: mixed, medium. FDA codified special controls for the device that require: clinical data showing improved knee function and relevant adverse events; non-clinical performance testing (mechanical function, durability, fretting/corrosion, static strength, wear, fatigue, worst-case range of motion); biocompatibility;…

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## Sources
- [2026-13101 on federalregister.gov](https://www.federalregister.gov/documents/2026/06/29/2026-13101/medical-devices-orthopedic-devices-classification-of-the-medial-knee-implanted-shock-absorber)
- [2026-13101 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-06-29/pdf/2026-13101.pdf)

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Source: PRIA, https://policyrisk.com/federal-register/2026-13101 (as of 2026-07-06).