# K202484: Cordera Hip System

- Pathway: 510(k) (Special)
- Applicant: Conformis, Inc.
- Decided: Sep 24, 2020 after 24 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K931641 (1994). 109 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190904: Conformis BeneFIT Hip System, Conformis, Inc. (2019) Summary page 4.
- K162719: iTotal® Hip Replacement System, Conformis, Inc. (2017) Summary page 4.
- K192198: Conformis Hip System, Conformis, Inc. (2019) Summary page 4.

## Most influential descendants
- K221104: Actera™ hip system (2022), 1 descendant of its own
- K231178: ACTERA™ hip system (2023), 0 descendants of its own

## Recalls of this device
- Mar 25, 2025 · Class II · Z-1569-2025: The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner.
- Jun 16, 2023 · Class II · Z-2405-2023: 30mm screws were labeled as 25mm screws.

## Indications for use
The Cordera™ Hip System may be used with iJigs® designed from a patient’s pre-operative CT scan, which must include certain necessary anatomic landmarks that are clearly identifiable. The Cordera™ 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 Cordera™ Hip System includes standard hip replacement components, and if selected, may use patient-specific single use instrumentation. The Conformis Cordera Hip System implants are intended for cementless fixation using an anterior or posterior surgical approach.

Source page: https://510kreport.com/device/K202484
Methodology: https://510kreport.com/methodology