510(k) · Cleared
Recalled · Class II · 2012Porous Coated Acetabular Components
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 Oct 4, 2005 as substantially equivalent to K921277 (Biomet, Inc., 1994) and 2 other predicates after a 258-day review. Its family tree reaches back 3 generations to 1985. 138 later devices descend from it. It has been recalled once.
- Decided
- Oct 4, 2005
- Review
- 258 days
- Class
- Class III
- Product code
- KWA
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K854046 (1985). 18 ancestors in all. 138 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK854046 Conical Collar Hip ProsthesisKirschner Medical Corp. · 1985
- 2 generations backK960303 Fenning Femoral ComponentBiomet, Inc. · 1996
- 1 generation backK030055 Mallory/Head Total Hip System; HA Mallory/Head Total Hip System…Biomet, Inc. · 2003 · Recalled
- This deviceK050124 Porous Coated Acetabular ComponentsBiomet, Inc. · 2005
- Descendant · cites it directly · 137 of its ownK070369 Regenerx Ringloc + Modular Acetabular ShellsBiomet, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 65 of its ownK093235 Ringloc + Hybrid Acetabular SystemBiomet, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 53 of its ownK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
- Descendant · 2 generations on · 53 of its ownK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
- Descendant · 4 generations on · 35 of its ownK140669 G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014
Showing 5 of 138 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 138 · See all- K070369Regenerx Ringloc + Modular Acetabular ShellsBiomet, Inc. · 2007 · cites it directly137descendants
- K093235Ringloc + Hybrid Acetabular SystemBiomet, Inc. · 2010 · 2 generations on65descendants
- K121874G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · 3 generations on53descendants
- K112802Pipeline Total Hip SystemPipeline Orthopedics · 2012 · 2 generations on53descendants
- K140669G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014 · 4 generations on35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K854046 | Conical Collar Hip Prosthesis | Kirschner Medical Corp. | 1985 | — |
| −2 | K960303 | Fenning Femoral Component | Biomet, Inc. | 1996 | — |
| −1 | K030055 | Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric… | Biomet, Inc. | 2003 | 3 |
| 0 (this device) | K050124 | Porous Coated Acetabular Components | Biomet, Inc. | 2005 | — |
| +1 | K070369 | Regenerx Ringloc + Modular Acetabular Shells | Biomet, Inc. | 2007 | 19 |
| +2 | K093235 | Ringloc + Hybrid Acetabular System | Biomet, Inc. | 2010 | 30 |
| +3 | K121874 | G7 Acetabular System | Biomet Manufacturing Corp | 2012 | 3 |
| +2 | K112802 | Pipeline Total Hip System | Pipeline Orthopedics | 2012 | — |
| +4 | K140669 | G7 Osseoti Acetublar Shells | Biomet, Inc. | 2014 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 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 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? (3)
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 |
|---|---|---|---|
| * | K921277 | Ranawat/Burstein Total Hip SystemSummary page 1…s 510(k) submission are substantially equivalent to devices cleared through the following 510(k)s: Ranawat Burstein® Total Hip System K921277 Full Hemisphere Ring-Loc Liner K920640 Expanded Indications for Non-cemented Poro… | 1994 |
| * | K920640 | Full Hemisphere Ring-Loc LinerSummary page 1…following 510(k)s: Ranawat Burstein® Total Hip System K921277 Full Hemisphere Ring-Loc Liner K920640 Expanded Indications for Non-cemented Porous Coated Hips K030055 Device Description: All devices are metallic, fu… | 1992 |
| * | K030055 | Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral…Summary page 1…K921277 Full Hemisphere Ring-Loc Liner K920640 Expanded Indications for Non-cemented Porous Coated Hips K030055 Device Description: All devices are metallic, full-hemisphere, acetabular shell components. Each shell utilizes a modular poly… | 2003 |
What descends from it? (138)
See all 1381 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070369 | Regenerx Ringloc + Modular Acetabular Shells | 2007 | 137 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 4, 2012 | Class II | Z-0415-2013 | Labeling Change Control | The color code on label conflicts with the liner size (liner size 24 should be green, not yellow) |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 7.1 years on median.
- 2 of the 18 ancestors have a recall of any class.
- Of its descendants, K070369 (Biomet, Inc., 2007) has gone furthest, with 137 descendants of its own.
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.
FDA decisions per year · KWA
4in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · KWA
76in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWA
19in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWA
1,216in 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?
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. M2aTM Ring-Loc…
Read the full statement (140 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.
M2aTM Ring-Loc liners are only cleared for use in non-cemented acetabular shells.
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, joint or bone loss, 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/K050124 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050124: Porous Coated Acetabular Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050124
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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