510(k) Report

510(k) · Cleared

Cleared

Metal-on-Metal Hip Systems-Additional Contraindications

K113271510(k) TraditionalCleared May 18, 2012196-day reviewClass III21 CFR 888.3330

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biomet Manufacturing, Inc. · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

Cleared on May 18, 2012 as substantially equivalent to K993438 (Biomet, Inc., 2000) and 7 other predicates after a 196-day review. Its family tree reaches back 6 generations to 1988.

Decided
May 18, 2012
Review
196 days
Class
Class III
Product code
KWA
Recalls
None
Predicates
8

Its longest line of descent runs back 6 generations to K881288 (1988). 50 ancestors in all, the oldest K830313 (1983). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestor2004: 1 other ancestor2001: 2 other ancestors2000: 7 other ancestors2005: 2 other ancestors2003: 3 other ancestors2002: 2 other ancestors1986: 2 other ancestors1998: 2 other ancestors1997: 4 other ancestors1996: 4 other ancestors1995: 2 other ancestors1994: 6 other ancestors1985: 2 other ancestors1983: 1 other ancestor1999: 2 other ancestors1991: 1 other ancestorK881288 · Corin Modular Moore Stem · Orthopedic Systems, Inc. · 1988K960538 · Opteon Unipolar · Exactech, Inc. · 1996K984028 · The New Bio-Moore Endo Heads · Biomet, Inc. · 1999K042037 · M2A Magnum System · Biomet, Inc. · 2004K061423 · M2A Magnum 12/14 Taper Inserts and One-Piece Modular Heads · Biomet Manufacturing Corp · 2006K082446 · Biomet Metal-on-Metal Hip Systems- Expanded Contraindications · Biomet, Inc. · 2008 · recalled1980198519901995200020052010
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 7 other ancestors3 generations back: 13 other ancestors4 generations back: 7 other ancestors5 generations back: 12 other ancestors K082446 · Biomet Metal-on-Metal Hip Systems- Expanded Contraindications · Biomet, Inc. · 2008 · recalledK061423 · M2A Magnum 12/14 Taper Inserts and One-Piece Modular Heads · Biomet Manufacturing Corp · 2006K042037 · M2A Magnum System · Biomet, Inc. · 2004K984028 · The New Bio-Moore Endo Heads · Biomet, Inc. · 1999K960538 · Opteon Unipolar · Exactech, Inc. · 1996K881288 · Corin Modular Moore Stem · Orthopedic Systems, Inc. · 1988−50
  1. Root · 6 generations backK881288 Corin Modular Moore StemOrthopedic Systems, Inc. · 1988
  2. 5 generations backK960538 Opteon UnipolarExactech, Inc. · 1996
  3. 4 generations backK984028 The New Bio-Moore Endo HeadsBiomet, Inc. · 1999
  4. 3 generations backK042037 M2A Magnum SystemBiomet, Inc. · 2004
  5. 2 generations backK061423 M2A Magnum 12/14 Taper Inserts and One-Piece Modular HeadsBiomet Manufacturing Corp · 2006
  6. 1 generation backK082446 Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc. · 2008 · Recalled
  7. This deviceK113271 Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc. · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K881288Corin Modular Moore StemOrthopedic Systems, Inc.1988—
−5K960538Opteon UnipolarExactech, Inc.1996—
−4K984028The New Bio-Moore Endo HeadsBiomet, Inc.1999—
−3K042037M2A Magnum SystemBiomet, Inc.2004—
−2K061423M2A Magnum 12/14 Taper Inserts and One-Piece Modular HeadsBiomet Manufacturing Corp2006—
−1K082446Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc.20081
0 (this device)K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198520
198620
199110
199460
199520
199640
199740
199820
199920
200070
200120
200220
200330
200410
200520
200610
FIG. 1 — Lineage of K113271, 1988–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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What was it cleared against? (8)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K993438Metal on Metal Acetabular System
Summary page 1
…d, porous-coated uncemented prosthesis. Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K993438 - Metal-On-Metal Acetabular Component K002379 - M2a Ringloc Acetabular Liner KO 11110 - M2a Acetabular Syst…
Biomet, Inc.2000—
*K002379M2A 28MM Ringloc Liner
Summary page 1
…coated uncemented prosthesis. Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K993438 - Metal-On-Metal Acetabular Component K002379 - M2a Ringloc Acetabular Liner KO 11110 - M2a Acetabular System K042037 - M2a Magnum System K042…
Biomet, Inc.2000—
*K011110M2A Acetabular SystemBiomet, Inc.2001—
*K042037M2A Magnum System
Summary page 1
…aimed: K993438 - Metal-On-Metal Acetabular Component K002379 - M2a Ringloc Acetabular Liner KO 11110 - M2a Acetabular System K042037 - M2a Magnum System K042841 - M2a / C2a Acetabular System K06 1423 - M2a Magnum 12/14 Taper Inserts and One…
Biomet, Inc.2004—
*K042841M2A/C2A Acetabular System
Summary page 1
…etal Acetabular Component K002379 - M2a Ringloc Acetabular Liner KO 11110 - M2a Acetabular System K042037 - M2a Magnum System K042841 - M2a / C2a Acetabular System K06 1423 - M2a Magnum 12/14 Taper Inserts and One-Piece Modular Heads K062995…
Biomet, Inc.2004—
*K061423M2A Magnum 12/14 Taper Inserts and One-Piece Modular Heads
Summary page 1
…a Ringloc Acetabular Liner KO 11110 - M2a Acetabular System K042037 - M2a Magnum System K042841 - M2a / C2a Acetabular System K06 1423 - M2a Magnum 12/14 Taper Inserts and One-Piece Modular Heads K062995 - M2a Magnum Tni-Spike Acetabular Component…
Biomet Manufacturing Corp2006—
*K062995M2A-Magnum Tri-Spike Acetabular Component
Summary page 1
…K042037 - M2a Magnum System K042841 - M2a / C2a Acetabular System K06 1423 - M2a Magnum 12/14 Taper Inserts and One-Piece Modular Heads K062995 - M2a Magnum Tni-Spike Acetabular Component K082446 - Biomet Metal-On-Metal Systems - Expanded Contraindications Mail…
Biomet Manufacturing Corp2006—
*K082446Biomet Metal-on-Metal Hip Systems- Expanded Contraindications
Summary page 1
…tabular System K06 1423 - M2a Magnum 12/14 Taper Inserts and One-Piece Modular Heads K062995 - M2a Magnum Tni-Spike Acetabular Component K082446 - Biomet Metal-On-Metal Systems - Expanded Contraindications Mailing Address: Shipping Address: P.O. Box 587…
Biomet, Inc.20081

Also cleared against K993438: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 24 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
  • 4 of the 50 ancestors have a recall of any class.
  • 6 other devices also cite its predicate K993438.

How does its category compare?

All KWA devices

KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · KWA

4in 2012

2007: 82008: 92009: 72010: 62011: 112012: 4
2007high 11 (2011) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWA

76in 2012

2007: 74 days median2008: 57 days median2009: 139 days median2010: 167 days median2011: 101 days median2012: 76 days median
2007high 167 (2010) · low 57 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWA

19in 2023

2008: 132010: 842011: 282012: 212013: 12016: 12017: 12018: 12019: 22020: 12023: 19
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

2007: 2132008: 7622009: 8202010: 3,3482011: 17,7372012: 24,6012013: 20,0202014: 16,4942015: 12,3392016: 7,8722017: 6,8472018: 6,3882019: 7,6282020: 4,5382021: 2,0642022: 1,6172023: 1,4742024: 1,1682025: 1,216
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20078740213
200895713762
200971390820
20106167843,348
2011111012817,737
20124762124,601
20130—120,020
20140—016,494
20150—012,339
20160—17,872
20170—16,847
20180—16,388
20190—27,628
20200—14,538
20210—02,064
20220—01,617
20230—191,474
20240—01,168
20250—01,216
20260—0—

What is it indicated for?

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. (a) Revision procedures where other treatment or devices have failed (M2a-Taper™ and M2a-Ringloc™). (b) Revision of previously failed total hip arthroplasty (M2a-Magnum™ and M2a-38™). 5. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head…

Read the full statement (116 words)

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.

2. Rheumatoid arthritis.

3. Correction of functional deformity.

4. (a) Revision procedures where other treatment or devices have failed (M2a-Taper™ and M2a-Ringloc™).

(b) Revision of previously failed total hip arthroplasty (M2a-Magnum™ and M2a-38™).

5. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

The components of the M2a Magnum™ system were also cleared for diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, slipped capital epiphysis, subcaptial fractures, and traumatic arthritis indications. The M2a-Taper™ Metal-on-Metal Hip Joint Replacement Prosthesis are intended for use in cemented and non-cemented primary and revision hip joint arthroplastic procedures.

Indications for use as stated in the FDA summary.

Also cleared against K993438

6 other devices cite the same predicate.

  • K131647Trinity Acetabular SystemCorin USA · 2013
  • K112019Bencox ID Stem, Bencox Metal Head, Bencox Bipolar CupCorentec Co., Ltd. · 2011
  • K103431Coren Total Hip SystemCorentec Co., Ltd. · 2011
  • K082446Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc. · 20081 recall
  • K042841M2A/C2A Acetabular SystemBiomet, Inc. · 2004
  • K033634Epsilon Metasul 32MM Acetabular Inserts, Standard and HoodedCenterpulse Orthopedics, Inc. · 20042 recalls

More from Biomet Manufacturing, Inc.

32 FDA decisions under this applicant name. See the company

  • K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc. · 20131 recall
  • K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc. · 2011
  • K080685Hiploc Compression Hip ScrewBiomet Manufacturing, Inc. · 20084 recalls
  • K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 20088 recalls
  • K071271Biomet Cable SystemBiomet Manufacturing, Inc. · 2007

Recent decisions in KWA

The KWA category page

  • K122778Profemur Z Revision Hip StemWrightmedicaltechnologyinc · 2012
  • K121544Dynasty Biofoam ShellWrightmedicaltechnologyinc · 2012
  • K113322Conserve Thin ShellWrightmedicaltechnologyinc · 2012
  • K112080Preserve Hip StemWrightmedicaltechnologyinc · 2011
  • K112150Profemur Gladiator HA Hip StemWrightmedicaltechnologyinc · 2011

https://510kreport.com/device/K113271 · printed Nov 3, 2026

Cite this page

510(k) Report. “K113271: Metal-on-Metal Hip Systems-Additional Contraindications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K113271

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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