# K162719: iTotal® Hip Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Conformis, Inc.
- Decided: Jun 14, 2017 after 258 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K931641 (1994). 106 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 124 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112802: Pipeline Total Hip System, Pipeline Orthopedics (2012) Summary page 5.
- K042992: Corail Amt Hip Prosthesis, DePuy Orthopaedics, Inc. (2005) Summary page 5.
- K111863: Signature Planner,Signature Guides, Materialise NV (2012) Summary page 5.

## Most influential descendants
- K192198: Conformis Hip System (2019), 12 descendants of its own
- 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
- K190904: Conformis BeneFIT Hip System (2019), 6 descendants of its own

## Recalls of this device
- Aug 22, 2019 · Class II · Z-0064-2020: Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
- Aug 22, 2019 · Class II · Z-0063-2020: Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
- Mar 29, 2019 · Class II · Z-1775-2019: Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants.
- Oct 16, 2018 · Class II · Z-0731-2019: The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm.

## Indications for use
The iTotal® Hip Replacement 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 iTotal® Hip Replacement 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 iTotal® Hip Replacement System includes standard hip replacement components as well as the following patient specific components: femoral neck, acetabular cup, single use instrumentation. The iTotal® Hip Replacement implants are intended for cementless fixation using an anterior or posterior surgical approach.

Source page: https://510kreport.com/device/K162719
Methodology: https://510kreport.com/methodology