510(k) · Cleared
Recalled · 2011Regenerx Ringloc + Modular Acetabular Shells
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Mar 9, 2007 as substantially equivalent to K050124 (Biomet, Inc., 2005) after a 29-day review. Its family tree reaches back 4 generations to 1985. 137 later devices descend from it. It has been recalled 19 times.
- Decided
- Mar 9, 2007
- Review
- 29 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 19
- Predicates
- 1
Its longest line of descent runs back 4 generations to K854046 (1985). 19 ancestors in all. 137 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK854046 Conical Collar Hip ProsthesisKirschner Medical Corp. · 1985
- 3 generations backK960303 Fenning Femoral ComponentBiomet, Inc. · 1996
- 2 generations backK030055 Mallory/Head Total Hip System; HA Mallory/Head Total Hip System…Biomet, Inc. · 2003 · Recalled
- 1 generation backK050124 Porous Coated Acetabular ComponentsBiomet, Inc. · 2005 · Recalled
- This deviceK070369 Regenerx Ringloc + Modular Acetabular ShellsBiomet, Inc. · 2007
- Descendant · cites it directly · 65 of its ownK093235 Ringloc + Hybrid Acetabular SystemBiomet, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 53 of its ownK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
- Descendant · cites it directly · 53 of its ownK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
- Descendant · 3 generations on · 35 of its ownK140669 G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014
- Descendant · 2 generations on · 21 of its ownK122158 PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012
Showing 5 of 137 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 137 · See all- K093235Ringloc + Hybrid Acetabular SystemBiomet, Inc. · 2010 · cites it directly65descendants
- K121874G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · 2 generations on53descendants
- K112802Pipeline Total Hip SystemPipeline Orthopedics · 2012 · cites it directly53descendants
- K140669G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014 · 3 generations on35descendants
- K122158PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012 · 2 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K854046 | Conical Collar Hip Prosthesis | Kirschner Medical Corp. | 1985 | — |
| −3 | K960303 | Fenning Femoral Component | Biomet, Inc. | 1996 | — |
| −2 | K030055 | Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric… | Biomet, Inc. | 2003 | 3 |
| −1 | K050124 | Porous Coated Acetabular Components | Biomet, Inc. | 2005 | 1 |
| 0 (this device) | K070369 | Regenerx Ringloc + Modular Acetabular Shells | Biomet, Inc. | 2007 | — |
| +1 | K093235 | Ringloc + Hybrid Acetabular System | Biomet, Inc. | 2010 | 30 |
| +2 | K121874 | G7 Acetabular System | Biomet Manufacturing Corp | 2012 | 3 |
| +1 | K112802 | Pipeline Total Hip System | Pipeline Orthopedics | 2012 | — |
| +3 | K140669 | G7 Osseoti Acetublar Shells | Biomet, Inc. | 2014 | — |
| +2 | K122158 | PBP Total Hip System | Pipeline Biomedical Products, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 8 | 0 |
| 2015 | 5 | 0 |
| 2016 | 6 | 0 |
| 2017 | 6 | 0 |
| 2018 | 6 | 0 |
| 2019 | 18 | 0 |
| 2020 | 6 | 0 |
| 2021 | 7 | 0 |
| 2022 | 12 | 0 |
| 2023 | 12 | 0 |
| 2024 | 12 | 0 |
| 2025 | 11 | 0 |
| 2026 | 16 | 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? (1)
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 |
|---|---|---|---|
| * | K050124 | Porous Coated Acetabular ComponentsSummary page 1…polymer, non-porous, caldum-phosphate 21 CFR 888.3353 Legally Marketed Devices To Which Substantial Equivalence is aaimed: Porous Coated Acetabular Components, 510(k) K050124, deared October 4, 2005 Device DescriptIon: All devices are metallic, hemispherical, modular acetabular shell components. AI shel… | 2005 |
What descends from it? (137)
See all 1375 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 14, 2011 | Not classified | Z-2465-2011 | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot… |
| Apr 14, 2011 | Not classified | Z-2457-2011 | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot… |
| Apr 14, 2011 | Not classified | Z-2453-2011 | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot… |
| Apr 14, 2011 | Not classified | Z-2466-2011 | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot… |
| Apr 14, 2011 | Not classified | Z-2448-2011 | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot… |
| Apr 14, 2011 | Not classified | Z-2458-2011 | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot… |
| Apr 14, 2011 | Not classified | Z-2462-2011 | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot… |
| Apr 14, 2011 | Not classified | Z-2449-2011 | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot… |
| Apr 14, 2011 | Not classified | Z-2452-2011 | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot… |
| Apr 14, 2011 | Not classified | Z-2461-2011 | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot… |
| Apr 14, 2011 | Not classified | Z-2455-2011 | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot… |
| Apr 14, 2011 | Not classified | Z-2464-2011 | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot… |
| Apr 14, 2011 | Not classified | Z-2456-2011 | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot… |
| Apr 14, 2011 | Not classified | Z-2450-2011 | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot… |
| Apr 14, 2011 | Not classified | Z-2451-2011 | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot… |
| Apr 14, 2011 | Not classified | Z-2460-2011 | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot… |
| Apr 14, 2011 | Not classified | Z-2454-2011 | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot… |
| Apr 14, 2011 | Not classified | Z-2459-2011 | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot… |
| Apr 14, 2011 | Not classified | Z-2463-2011 | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot… |
The 5 latest of 19 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 7.1 years on median.
- 3 of the 19 ancestors have a recall of any class.
- Of its descendants, K093235 (Biomet, Inc., 2010) has gone furthest, with 65 descendants of its own.
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. 2007, this device’s year, is highlighted.
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?
Cemented or non-cemented total hip replacement in cases of: 1. Non-inflammatory 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 by other techniques. 5. Revision procedures where other treatment or devices have failed. The Indications…
Read the full statement (128 words)
Cemented or non-cemented total hip replacement in cases of:
1. Non-inflammatory 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 by other techniques.
5. Revision procedures where other treatment or devices have failed.
The Indications for use of the constrained liners compatible with this system are as follow:
The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery 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 and for whom all other options to constrained acetabular components have been considered.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070369 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070369: Regenerx Ringloc + Modular Acetabular Shells.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070369
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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