510(k) · Cleared
ClearedPorous Titanium Acetabular Shells
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Apr 28, 2006 as substantially equivalent to K001759 (Implex Corp., 2000) and 1 other predicate after a 185-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Apr 28, 2006
- Review
- 185 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K983837 (1999). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK983837 Hedrocel Acetabular Cage SystemImplex Corp. · 1999
- This deviceK052996 Porous Titanium Acetabular ShellsBiomet Manufacturing Corp · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983837 | Hedrocel Acetabular Cage System | Implex Corp. | 1999 | — |
| 0 (this device) | K052996 | Porous Titanium Acetabular Shells | Biomet Manufacturing Corp | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LPH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K001759 | Hedrocel Revision Cup, Model 02-2YY-ZZZZSummary page 1…semi-constrained cemented or non porous uncemented prosthesis (888.3353) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Hedrocel® Revision Shells (K001759), Hedrocel® Acetabular Cages (K983837) Device Description: Porous Titanium Acetabular Shells are Intended for use in reconstruct… | 2000 |
| * | K983837 | Hedrocel Acetabular Cage SystemSummary page 1…s uncemented prosthesis (888.3353) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Hedrocel® Revision Shells (K001759), Hedrocel® Acetabular Cages (K983837) Device Description: Porous Titanium Acetabular Shells are Intended for use in reconstruction of the hip joint due to disease, d… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K001759.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
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…
Read the full statement (503 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052996 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052996: Porous Titanium Acetabular Shells.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052996
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026