# K192198: Conformis Hip System

- Pathway: 510(k) (Special)
- Applicant: Conformis, Inc.
- Decided: Nov 6, 2019 after 85 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.
12 later devices descend from it; 4 cite it directly.
0 of 120 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 4.

## Most influential descendants
- K213389: Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System (2021), 8 descendants of its own
- K221059: Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) (2022), 7 descendants of its own
- K221404: Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) (2022), 6 descendants of its own
- K223316: Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System (2023), 2 descendants of its own
- K230846: iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System (2023), 2 descendants of its own

## Recalls of this device
- Sep 21, 2020 · Class II · Z-0475-2021: Incorrect hip components were provided in kits.

## Indications for use
The Conformis Hip System is designed from a patient’s pre-operative CT scan which must include certain necessary anatomic landmarks that are clearly identifiable. Total hip replacement using the Conformis 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 Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation. The Conformis Hip System implants are intended for cementless fixation using an anterior or posterior surgical approach.

Source page: https://510kreport.com/device/K192198
Methodology: https://510kreport.com/methodology