510(k) · Cleared
ClearedM2A Magnum 12/14 Taper Inserts and One-Piece Modular Heads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Cleared on Jul 27, 2006 as substantially equivalent to K042037 (Biomet, Inc., 2004) and 2 other predicates after a 65-day review. Its family tree reaches back 4 generations to 1988. 3 later devices descend from it.
- Decided
- Jul 27, 2006
- Review
- 65 days
- Class
- Class III
- Product code
- KWA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K881288 (1988). 42 ancestors in all, the oldest K830313 (1983). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK881288 Corin Modular Moore StemOrthopedic Systems, Inc. · 1988
- 3 generations backK960538 Opteon UnipolarExactech, Inc. · 1996
- 2 generations backK984028 The New Bio-Moore Endo HeadsBiomet, Inc. · 1999
- 1 generation backK042037 M2A Magnum SystemBiomet, Inc. · 2004
- This deviceK061423 M2A Magnum 12/14 Taper Inserts and One-Piece Modular HeadsBiomet Manufacturing Corp · 2006
- Descendant · cites it directly · 2 of its ownK082446 Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc. · 2008 · Recalled
- Descendant · cites it directly · 0 of its ownK113271 Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK083642 Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc. · 2009
Most influential descendants
Showing 3 of 3 · See all- K082446Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc. · 2008 · cites it directly2descendants
- K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc. · 2012 · cites it directly0descendants
- K083642Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K881288 | Corin Modular Moore Stem | Orthopedic Systems, Inc. | 1988 | — |
| −3 | K960538 | Opteon Unipolar | Exactech, Inc. | 1996 | — |
| −2 | K984028 | The New Bio-Moore Endo Heads | Biomet, Inc. | 1999 | — |
| −1 | K042037 | M2A Magnum System | Biomet, Inc. | 2004 | — |
| 0 (this device) | K061423 | M2A Magnum 12/14 Taper Inserts and One-Piece Modular Heads | Biomet Manufacturing Corp | 2006 | — |
| +1 | K082446 | Biomet Metal-on-Metal Hip Systems- Expanded Contraindications | Biomet, Inc. | 2008 | 1 |
| +1 | K113271 | Metal-on-Metal Hip Systems-Additional Contraindications | Biomet Manufacturing, Inc. | 2012 | — |
| +2 | K083642 | Depuy Pinnacle Metal-on-Metal Acetabular Cup Liners | DePuy Orthopaedics, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 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 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 |
|---|---|---|---|
| * | K042037 | M2A Magnum SystemSummary page 1…cemented acetabular component prosthesis (888.3330) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: M2a MagnumTM Systems- K(042037 (Biomet, Inc.); ASRTM Modular Acetabular Cup System-K040627 (DePuy Orthopaedics, Inc.), and TaperLoc® 12/14 Taper Femoral Compone… | 2004 |
| * | K040627 | Depuy Asr Modular Acetabular Cup SystemSummary page 1…hesis (888.3330) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: M2a MagnumTM Systems- K(042037 (Biomet, Inc.); ASRTM Modular Acetabular Cup System-K040627 (DePuy Orthopaedics, Inc.), and TaperLoc® 12/14 Taper Femoral Components-K043537 (Biomnet, Inc.). Device Description: The M2a Ma… | 2005 |
| * | K043537 | Taperloc 12/14 Taper Femoral ComponentsSummary page 1…imed: M2a MagnumTM Systems- K(042037 (Biomet, Inc.); ASRTM Modular Acetabular Cup System-K040627 (DePuy Orthopaedics, Inc.), and TaperLoc® 12/14 Taper Femoral Components-K043537 (Biomnet, Inc.). Device Description: The M2a MagnumTM 12/14 Taper Inserts and One-Piece Modular Heads are designed for use with… | 2005 |
What descends from it? (3)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 3 of the 42 ancestors have a recall of any class.
- Of its descendants, K082446 (Biomet, Inc., 2008) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K042037.
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?
The M2a Magnum TM 12/14 Taper Inserts and One-Piece Modular Heads are indicated
for use in patients requiring total hip replacement due to the following:
1. Non-inflammatory degenerative joint disease including avascular necrosis,
diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, osteoarthritis,
slipped capital epiphysis, subcapital fractures and traumatic arthritis.
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 of previously failed total hip arthroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061423 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061423: M2A Magnum 12/14 Taper Inserts and One-Piece Modular Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061423
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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