# K101472: Multifit Total Hip System

- Pathway: 510(k) (Abbreviated)
- Applicant: Otis Biotech Co., Ltd.
- Decided: Jan 5, 2011 after 223 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- 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: 6 generations back to K935452 (1994). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011489: Summit Duofix Hip Prosthesis, DePuy Orthopaedics, Inc. (2001) Summary page 2.
- K982032: Osteonics Omnifit HA Hip Stem Series, Osteonics Secur-Fit HA Hip Stem Series, Osteonics Primary Secur-Fit Plus Hip Stems, Osteonics Corp. (1998) Summary page 2.
- K972641: Dual Offset Perfecta Imc Hip Stem, Wrightmedicaltechnologyinc (1997) Summary page 2.
- K990369: Synergy Cemented Hip Stem, Smith & Nephew, Inc. (1999) Summary page 2.
- K934765: Trilogy Acetabular System, Zimmer, Inc. (1994) Summary page 2.
- K002747: Reflection Cross-Linked Uhmwpe Acetabular Components, Smith & Nephew, Inc. (2000) Summary page 2.
- K812672: Self-Centering Hip, Depuy, Inc. (1981) Summary page 2.
- K051569: Ringloc BI-Polar Acetabular Component, Biomet, Inc. (2005) Summary page 2.
- K021673: Total Hip Femoral Head - 12/14 Taper, Smith & Nephew, Inc. (2002) Summary page 2.
- K911684: Biomet Cobalt-Chrome Femoral Components, Biomet, Inc. (1991) Summary page 2.

## Indications for use
The hip system is intended to be cemented stem or un cemented stem use. The MultiFit Total Hip System is to replace a defective hip joint in the following cases: 1) Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur; 2) Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis; 3) Patients suffering from disability due to previous fusion and previously failed endo-prostheses; 4) Patients with acute femoral neck fractures.

Source page: https://510kreport.com/device/K101472
Methodology: https://510kreport.com/methodology