# K231178: ACTERA™ hip system

- Pathway: 510(k) (Special)
- Applicant: Conformis, Inc.
- Decided: May 23, 2023 after 27 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K941847 (1994). 261 ancestors in all.
No later device cites it as a predicate yet.
0 of 261 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221104: Actera™ hip system, Conformis, Inc. (2022) Summary page 4.
- K192198: Conformis Hip System, Conformis, Inc. (2019) Summary page 4.

## Indications for use
The ACTERA™ hip system may be designed from a patient’s preoperative CT scan which must include certain necessary anatomic landmarks that are clearly identifiable. 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/K231178
Methodology: https://510kreport.com/methodology