510(k) · Cleared
ClearedM2A-Magnum Tri-Spike Acetabular Component
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 Oct 31, 2006 as substantially equivalent to K042037 (Biomet, Inc., 2004) after a 29-day review. Its family tree reaches back 4 generations to 1988. 26 later devices descend from it.
- Decided
- Oct 31, 2006
- Review
- 29 days
- Class
- Class III
- Product code
- KWA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K881288 (1988). 15 ancestors in all, the oldest K845025 (1985). 26 later devices descend from it, 3 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 deviceK062995 M2A-Magnum Tri-Spike Acetabular ComponentBiomet Manufacturing Corp · 2006
- Descendant · cites it directly · 22 of its ownK110555 Arcomxl Active ArticulationBiomet Manufacturing Corp · 2011 · Recalled
- Descendant · 2 generations on · 21 of its ownK150522 G7 Dual Mobility SystemBiomet, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 10 of its ownK170359 Trinity™ Dual Mobility SystemCorin U.S.A. Limited · 2017 · Recalled
- Descendant · 2 generations on · 7 of its ownK161190 G7 Dual Mobility System, Active Articulation SystemBiomet, Inc. · 2016
- Descendant · 4 generations on · 3 of its ownK191831 MobiliT CupCorin U.S.A. Limited · 2020
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K110555Arcomxl Active ArticulationBiomet Manufacturing Corp · 2011 · cites it directly22descendants
- K150522G7 Dual Mobility SystemBiomet, Inc. · 2015 · 2 generations on21descendants
- K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited · 2017 · 3 generations on10descendants
- K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc. · 2016 · 2 generations on7descendants
- K191831MobiliT CupCorin U.S.A. Limited · 2020 · 4 generations on3descendants
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) | K062995 | M2A-Magnum Tri-Spike Acetabular Component | Biomet Manufacturing Corp | 2006 | — |
| +1 | K110555 | Arcomxl Active Articulation | Biomet Manufacturing Corp | 2011 | 2 |
| +2 | K150522 | G7 Dual Mobility System | Biomet, Inc. | 2015 | 1 |
| +3 | K170359 | Trinity™ Dual Mobility System | Corin U.S.A. Limited | 2017 | 1 |
| +2 | K161190 | G7 Dual Mobility System, Active Articulation System | Biomet, Inc. | 2016 | — |
| +4 | K191831 | MobiliT Cup | Corin U.S.A. Limited | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K042037 | M2A Magnum SystemSummary page 1…ned, with uncemented acetabular component prosthesis (21 CFR 888.3330) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: MV2a-Magnum m System, 510(k) K042037. Device Description: The M2a-MagnuMm T Tri-Spike~ Acetabular Components isa Co-Cr-Mo, full hemisphere shell in outer diameter… | 2004 |
What descends from it? (26)
See all 263 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.
- None of the 15 ancestors has a recall.
- Of its descendants, K110555 (Biomet Manufacturing Corp, 2011) has gone furthest, with 22 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-MagnumTM System is indicated for non-cemented use in patients requiring total hip replacement due to the following:
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.
Rheumatoid arthritis
Correction of functional deformity
* Treatment of non-union, femoral neck fracture, and trochanteric fractures of the
proximal femur with head involvement, unmanageable by other techniques
* Revision of previously failed total hip arthroplasty
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062995: M2A-Magnum Tri-Spike Acetabular Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062995
Report an extraction error
Are you the manufacturer?
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