510(k) · Cleared
Recalled · Class II · 2017Ringloc + Hybrid Acetabular System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Cleared on Apr 30, 2010 as substantially equivalent to K002379 (Biomet, Inc., 2000) and 1 other predicate after a 197-day review. Its family tree reaches back 5 generations to 1985. 65 later devices descend from it. It has been recalled 30 times.
- Decided
- Apr 30, 2010
- Review
- 197 days
- Class
- Class III
- Product code
- KWA
- Recalls
- 30
- Predicates
- 2
Its longest line of descent runs back 5 generations to K854046 (1985). 21 ancestors in all. 65 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK854046 Conical Collar Hip ProsthesisKirschner Medical Corp. · 1985
- 4 generations backK960303 Fenning Femoral ComponentBiomet, Inc. · 1996
- 3 generations backK030055 Mallory/Head Total Hip System; HA Mallory/Head Total Hip System…Biomet, Inc. · 2003 · Recalled
- 2 generations backK050124 Porous Coated Acetabular ComponentsBiomet, Inc. · 2005 · Recalled
- 1 generation backK070369 Regenerx Ringloc + Modular Acetabular ShellsBiomet, Inc. · 2007 · Recalled
- This deviceK093235 Ringloc + Hybrid Acetabular SystemBiomet, Inc. · 2010
- Descendant · cites it directly · 53 of its ownK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
- Descendant · 2 generations on · 35 of its ownK140669 G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014
- Descendant · 2 generations on · 17 of its ownK142882 G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc. · 2015
- Descendant · 3 generations on · 8 of its ownK221479 Persona Personalized Knee SystemZimmer, Inc. · 2022
- Descendant · 2 generations on · 8 of its ownK182321 MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG · 2019
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
2012high 12 (2026) · low 0 (2013)2026
Most influential descendants
Showing 5 of 65 · See all- K121874G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · cites it directly53descendants
- K140669G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014 · 2 generations on35descendants
- K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc. · 2015 · 2 generations on17descendants
- K221479Persona Personalized Knee SystemZimmer, Inc. · 2022 · 3 generations on8descendants
- K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG · 2019 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K854046 | Conical Collar Hip Prosthesis | Kirschner Medical Corp. | 1985 | — |
| −4 | K960303 | Fenning Femoral Component | Biomet, Inc. | 1996 | — |
| −3 | K030055 | Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric… | Biomet, Inc. | 2003 | 3 |
| −2 | K050124 | Porous Coated Acetabular Components | Biomet, Inc. | 2005 | 1 |
| −1 | K070369 | Regenerx Ringloc + Modular Acetabular Shells | Biomet, Inc. | 2007 | 19 |
| 0 (this device) | K093235 | Ringloc + Hybrid Acetabular System | Biomet, Inc. | 2010 | — |
| +1 | K121874 | G7 Acetabular System | Biomet Manufacturing Corp | 2012 | 3 |
| +2 | K140669 | G7 Osseoti Acetublar Shells | Biomet, Inc. | 2014 | — |
| +2 | K142882 | G7 Freedom and Offset Liners, Freedom Head, Size 32 | Biomet, Inc. | 2015 | — |
| +3 | K221479 | Persona Personalized Knee System | Zimmer, Inc. | 2022 | — |
| +2 | K182321 | MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 2019 | — |
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 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 9 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 7 | 0 |
| 2025 | 7 | 0 |
| 2026 | 12 | 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 KWA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K002379 | M2A 28MM Ringloc LinerSummary page 1…KWA, LPH, LZO Legally Marketed Devices To Which Substantial Equivalence Is Claimed: M2a Ringloc® Acetabular Liners - K002379 Regenerex Ringloc®+ Modular Acetabular Shell - K070369 Device Description: The Porous Pl… | 2000 |
| * | K070369 | Regenerx Ringloc + Modular Acetabular ShellsSummary page 1…M2a Ringloc® Acetabular Liners - K002379 Regenerex Ringloc®+ Modular Acetabular Shell - K070369 Device Description: The Porous Plasma Spray (PPS) Ringloc®± Acetabular System is a series of acetabular shells that incorporate t… | 2007 |
What descends from it? (65)
See all 653 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 |
|---|---|---|---|---|
| Jun 29, 2017 | Class II | Z-0312-2018 | Employee error | Device was distributed with the etching missing from the product. |
| Jul 28, 2015 | Class II | Z-2483-2015 | Under Investigation by firm | The device was assembled without screw hole plugs. |
| Jan 9, 2015 | Class II | Z-1123-2015 | Packaging process control | Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two. |
| Apr 14, 2011 | Not classified | Z-2425-2011 | 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-2433-2011 | 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-2447-2011 | 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-2445-2011 | 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-2421-2011 | 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-2428-2011 | 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-2422-2011 | 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-2430-2011 | 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-2444-2011 | 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-2432-2011 | 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-2441-2011 | 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-2424-2011 | 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-2431-2011 | 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-2426-2011 | 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-2435-2011 | 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-2423-2011 | 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-2438-2011 | 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-2442-2011 | 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-2446-2011 | 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-2434-2011 | 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-2427-2011 | 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-2436-2011 | 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-2440-2011 | 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-2437-2011 | 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-2443-2011 | 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-2439-2011 | 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-2429-2011 | 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 30 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 25 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- 4 of the 21 ancestors have a recall of any class.
- Of its descendants, K121874 (Biomet Manufacturing Corp, 2012) has gone furthest, with 53 descendants of its own.
- 4 other devices also cite its predicate K002379.
How does its category compare?
All KWA devicesKWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KWA
4in 2012
2007high 11 (2011) · low 0 (2013)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · KWA
76in 2012
2007high 167 (2010) · low 57 (2008)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWA
19in 2023
2007high 84 (2010) · low 0 (2007)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWA
1,216in 2025
2007high 24,601 (2012) · low 213 (2007)2025
MAUDE reports naming product code KWA, 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 | 8 | 74 | 0 | 213 |
| 2008 | 9 | 57 | 13 | 762 |
| 2009 | 7 | 139 | 0 | 820 |
| 2010 | 6 | 167 | 84 | 3,348 |
| 2011 | 11 | 101 | 28 | 17,737 |
| 2012 | 4 | 76 | 21 | 24,601 |
| 2013 | 0 | — | 1 | 20,020 |
| 2014 | 0 | — | 0 | 16,494 |
| 2015 | 0 | — | 0 | 12,339 |
| 2016 | 0 | — | 1 | 7,872 |
| 2017 | 0 | — | 1 | 6,847 |
| 2018 | 0 | — | 1 | 6,388 |
| 2019 | 0 | — | 2 | 7,628 |
| 2020 | 0 | — | 1 | 4,538 |
| 2021 | 0 | — | 0 | 2,064 |
| 2022 | 0 | — | 0 | 1,617 |
| 2023 | 0 | — | 19 | 1,474 |
| 2024 | 0 | — | 0 | 1,168 |
| 2025 | 0 | — | 0 | 1,216 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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 Porous Plasma Spray (PPS) Ringloc®± Acetabular System is intended for uncemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093235 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093235: Ringloc + Hybrid Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093235
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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