# K221104: Actera™ hip system

- Pathway: 510(k) (Traditional)
- Applicant: Conformis, Inc.
- Decided: Aug 4, 2022 after 112 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K941847 (1994). 260 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 261 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210581: Actis DuoFix Hip Prosthesis- Collarless, Depuy Ireland UC (2021) Summary page 4.
- K202484: Cordera Hip System, Conformis, Inc. (2020) Summary page 4.

## Most influential descendants
- K231178: ACTERA™ hip system (2023), 0 descendants of its own

## Recalls of this device
- Jun 16, 2023 · Class II · Z-2405-2023: 30mm screws were labeled as 25mm screws.

## Indications for use
Total hip replacement using the Actera™ hip system is indicated for use in skeletally mature individuals undergoing total hip replacement due to: • A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia. • Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. • Revision procedures for failed previous hip surgery (excluding situations where hardware is present). The Actera™ hip system implants are intended for cementless fixation using an anterior, lateral or posterior surgical technique.

Source page: https://510kreport.com/device/K221104
Methodology: https://510kreport.com/methodology