# K101072: Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-Apatite

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Apr 11, 2011 after 357 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- 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 K955033 (1996). 64 ancestors in all.
22 later devices descend from it; 1 cites it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081171: Tritanium Acetabular Shell System, Howmedica Osteonics Corp. (2008) Summary page 2.
- K971206: Meridian ST Femoral Stem and Vitalock Solid Back Shell W/ Peri-Apatite Coating, Howmedica Corp. (1998) Summary page 1.
- K953111: Corail, Landos, Inc. (1996)
- K043079: Bicontact Hip System with U-Cap, Aesculap (2004) Summary page 1.
- K090982: Smith & Nephew Hip Systems with HA, Smith & Nephew, Inc. (2010). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K122158: PBP Total Hip System (2012), 21 descendants of its own
- K131237: Pipeline Total Hip System (2013), 20 descendants of its own
- K161184: iNSitu Total Hip System (2016), 19 descendants of its own
- K163577: Ecofit® Hip System (2017), 9 descendants of its own
- K172501: iNSitu Total Hip System (2017), 7 descendants of its own

## Indications for use
The indications for use of the total hip replacement prostheses include: 1. Painful, disabling joint disease of the hip resulting from: non-inflammatory degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis. 2. Revision of previous failed femoral head replacement, shell arthroplasty or other procedure. 3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. 4. Where bone stock is of poor bone quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum. Additional indications for use when using constrained liners: The device is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intra-operative instability. Additional indications for use when using modular dual mobility (MDM) liners: The device is indicated for use as a component of a total hip prosthesis and include: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2. Rheumatoid arthritis; 3. Correction of functional deformity; 4. Revision procedures where other treatments or devices have failed; 5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; and 6. Dislocation risks The MDM liners are intended for cementless use only. The acetabular shell is intended for cementless use only.

Source page: https://510kreport.com/device/K101072
Methodology: https://510kreport.com/methodology