# K052996: Porous Titanium Acetabular Shells

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Apr 28, 2006 after 185 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: 1 generation back to K983837 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001759: Hedrocel Revision Cup, Model 02-2YY-ZZZZ, Implex Corp. (2000) Summary page 1.
- K983837: Hedrocel Acetabular Cage System, Implex Corp. (1999) Summary page 1.

## Indications for use
The Porous Titanium Acetabular Shells are indicated for cemented or non-cemented use in total hip replacement in cases of: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty. Specific indications for compatible components (femorals, heads, liners, and screws) that can be used with the Regenerex tm Hip Products include: Freedom® Constrained Liners (K030047) The Biomet Freedom® Constrained liner is indicated for use as a component of a total hip prosthesis in primary and/or revision patients at high risk of hip dislocation due to history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. Tri-Polar System (K991990) Indication #5 (Revision of previously failed total hip arthroplasty) is further specified to include recurrent dislocation. OSS/Salvaqe Systems/Total Femur (K974558, K002757, K021380, K033871) Salvage/Oncology Hip and Total Femur components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrodesis. Interlocking Stems (K990830, K042774) Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard type hip replacement prosthesis. HA IPMVI HiD Femoral Stems (K-03-0-048) Non-cemented use for skeletally mature patients undergoing primary hip replacement surgery as a result of non-inflammatory degenerative joint disease. Gross H-ip Femoral (K<001580') and Bohn HID Femoral (K000262) These femoral components are also indicated for treatment in conjunction with tumor resection and trauma. Taoer 2 W Porous Femoral (K<050441) and Balance Microplasty (1<050251') Indication #5 (Revision of previously failed total hip arthroplasty) is not applicable for these components. These stems are indicated for the revision of previously failed femoral head resurfacing component. Color Buffed Femoral (K<992903). CB DDH Femoral (1<012019'). Bi-Metric Hip) (K<992058'). CB Answer Femoral (1<991987). Reach Femoral (1<982367) Indication #5 (Revision of previously failed total hip arthroplasty) is not applicable for these components. The statement should read, TMRevisions of hip replacement components". 150mm Bi-Metric: Hip Stem (K983710') Indication #5 (Revision of previously failed total hip arthroplasty) is not applicable for these components. They are not indicated for revision procedures. Zirconia Ceramic Heads (K964431 and 1<991708) Indication #4 (Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques) is not applicable to these Zirconia Ceramic Heads. BioloxtW delta Ceramic Heads (K<042091'). Rx9O) h Standard/Lateralized Femoral (K<023085'). Portrait Femoral (K<010560). Mallory/Head Smooth Femoral (K<994007), Generation 4 Polished Femoral (K<031734), Modular Reach Femoral (K<994038). Indication #5 (Revision of previously failed total hip arthroplasty) is not applicable for these components. The statement should read, "Revision procedures where other treatment or devices have failed'. Medallion Modular Hit) System (K<041850) Same list of five indications but cleared for uncemented use only.

Source page: https://510kreport.com/device/K052996
Methodology: https://510kreport.com/methodology