# K190904: Conformis BeneFIT Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Conformis, Inc.
- Decided: Aug 28, 2019 after 142 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- 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: 9 generations back to K931641 (1994). 107 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162719: iTotal® Hip Replacement System, Conformis, Inc. (2017) Summary page 5.
- K042992: Corail Amt Hip Prosthesis, DePuy Orthopaedics, Inc. (2005) Summary page 5.
- K102795: Signature Planner; Signature Guides, Materialise NV (2011) Summary page 5.

## Most influential descendants
- K202484: Cordera Hip System (2020), 2 descendants of its own
- K221104: Actera™ hip system (2022), 1 descendant of its own
- K220468: BENCOX Mirabo Cup System (2022), 1 descendant of its own
- K252067: Velora Acetabular System (2025), 0 descendants of its own
- 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
The ConforMIS BeneFIT 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, manageable by other techniques. • Revision procedures for failed previous hip surgery (excluding situations where hardware is present). The ConforMIS BeneFIT Hip System implants are intended for cementless fixation using an anterior or posterior surgical approach.

Source page: https://510kreport.com/device/K190904
Methodology: https://510kreport.com/methodology