510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

Biomet Metal-on-Metal Hip Systems- Expanded Contraindications

K082446510(k) TraditionalCleared Oct 15, 200851-day reviewClass III21 CFR 888.3330Recalls 1

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

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

Cleared on Oct 15, 2008 as substantially equivalent to K993438 (Biomet, Inc., 2000) and 7 other predicates after a 51-day review. Its family tree reaches back 5 generations to 1988. 2 later devices descend from it. It has been recalled once.

Decided
Oct 15, 2008
Review
51 days
Class
Class III
Product code
KWA
Recalls
1
Predicates
8

Its longest line of descent runs back 5 generations to K881288 (1988). 47 ancestors in all, the oldest K830313 (1983). 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2005: 2 other ancestors2001: 2 other ancestors2000: 7 other ancestors2003: 3 other ancestors2002: 2 other ancestors1996: 4 other ancestors1994: 6 other ancestors1983: 1 other ancestor1999: 2 other ancestors1998: 2 other ancestors1997: 4 other ancestors1995: 2 other ancestors1985: 2 other ancestors1991: 1 other ancestor1986: 1 other ancestor2012: 1 descendant cleared2009: 1 descendant clearedK881288 · 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 · 200619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 9 other ancestors3 generations back: 14 other ancestors4 generations back: 13 other ancestors 1 generation forward: 2 descendants K061423 · 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 · 5 generations backK881288 Corin Modular Moore StemOrthopedic Systems, Inc. · 1988
  2. 4 generations backK960538 Opteon UnipolarExactech, Inc. · 1996
  3. 3 generations backK984028 The New Bio-Moore Endo HeadsBiomet, Inc. · 1999
  4. 2 generations backK042037 M2A Magnum SystemBiomet, Inc. · 2004
  5. 1 generation backK061423 M2A Magnum 12/14 Taper Inserts and One-Piece Modular HeadsBiomet Manufacturing Corp · 2006
  6. This deviceK082446 Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc. · 2008
  7. Descendant · cites it directly · 0 of its ownK113271 Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc. · 2012
  8. Descendant · cites it directly · 0 of its ownK083642 Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc. · 2009

Most influential descendants

Showing 2 of 2 · See all
  • K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc. · 2012 · cites it directly0descendants
  • K083642Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K881288Corin Modular Moore StemOrthopedic Systems, Inc.1988—
−4K960538Opteon UnipolarExactech, Inc.1996—
−3K984028The New Bio-Moore Endo HeadsBiomet, Inc.1999—
−2K042037M2A Magnum SystemBiomet, Inc.2004—
−1K061423M2A Magnum 12/14 Taper Inserts and One-Piece Modular HeadsBiomet Manufacturing Corp2006—
0 (this device)K082446Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc.2008—
+1K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc.2012—
+1K083642Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198520
198610
199110
199460
199520
199640
199740
199820
199920
200070
200120
200220
200330
200520
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201210
FIG. 1 — Lineage of K082446, 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
Get a 510(k) Report

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
…semi-constrained, with uncemented acetabular component prosthesis Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Metal-on-Metal Acetabular System-K993438 (Biomet, Inc.) M2a TM 28mm RingLoc TM Liner-K002379 (Biomet, Inc.) M2a TM 32mm Taper System-K003363 (Biomet, Inc.) M2a Tm Acetabu…
Biomet, Inc.2000—
*K002379M2A 28MM Ringloc Liner
Summary page 1
…nt prosthesis Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Metal-on-Metal Acetabular System-K993438 (Biomet, Inc.) M2a TM 28mm RingLoc TM Liner-K002379 (Biomet, Inc.) M2a TM 32mm Taper System-K003363 (Biomet, Inc.) M2a Tm Acetabular System--K011110 (Biomet, Inc.) M2a-Magnum TM Sys…
Biomet, Inc.2000—
*K003363M2A 32MM Taper System
Summary page 1
…Substantial Equivalence Is Claimed: Metal-on-Metal Acetabular System-K993438 (Biomet, Inc.) M2a TM 28mm RingLoc TM Liner-K002379 (Biomet, Inc.) M2a TM 32mm Taper System-K003363 (Biomet, Inc.) M2a Tm Acetabular System--K011110 (Biomet, Inc.) M2a-Magnum TM System-K042037 (Biomet, Inc.) TaperLoc® 12/14 Femor…
Biomet, Inc.2000—
*K011110M2A Acetabular System
Summary page 1
…al Acetabular System-K993438 (Biomet, Inc.) M2a TM 28mm RingLoc TM Liner-K002379 (Biomet, Inc.) M2a TM 32mm Taper System-K003363 (Biomet, Inc.) M2a Tm Acetabular System--K011110 (Biomet, Inc.) M2a-Magnum TM System-K042037 (Biomet, Inc.) TaperLoc® 12/14 Femoral Components and One-Piece Modular Heads-K043537…
Biomet, Inc.2001—
*K042037M2A Magnum System
Summary page 1
…M2a TM 28mm RingLoc TM Liner-K002379 (Biomet, Inc.) M2a TM 32mm Taper System-K003363 (Biomet, Inc.) M2a Tm Acetabular System--K011110 (Biomet, Inc.) M2a-Magnum TM System-K042037 (Biomet, Inc.) TaperLoc® 12/14 Femoral Components and One-Piece Modular Heads-K043537 (Biomet, Inc.) M2a Magnum' T M 12/14 Taper…
Biomet, Inc.2004—
*K043537Taperloc 12/14 Taper Femoral Components
Summary page 1
…Biomet, Inc.) M2a Tm Acetabular System--K011110 (Biomet, Inc.) M2a-Magnum TM System-K042037 (Biomet, Inc.) TaperLoc® 12/14 Femoral Components and One-Piece Modular Heads-K043537 (Biomet, Inc.) M2a Magnum' T M 12/14 Taper Inserts and One-Piece Modular Heads-K061423 (Biomet, Inc.) M2a-Magnum' m Tri-Spike Tm…
Biomet, Inc.2005—
*K061423M2A Magnum 12/14 Taper Inserts and One-Piece Modular Heads
Summary page 1
…2037 (Biomet, Inc.) TaperLoc® 12/14 Femoral Components and One-Piece Modular Heads-K043537 (Biomet, Inc.) M2a Magnum' T M 12/14 Taper Inserts and One-Piece Modular Heads-K061423 (Biomet, Inc.) M2a-Magnum' m Tri-Spike Tm Acetabular Component-K062995 (Biomet, Inc.) Device Description: The systems consist of…
Biomet Manufacturing Corp2006—
*K062995M2A-Magnum Tri-Spike Acetabular Component
Summary page 1
…dular Heads-K043537 (Biomet, Inc.) M2a Magnum' T M 12/14 Taper Inserts and One-Piece Modular Heads-K061423 (Biomet, Inc.) M2a-Magnum' m Tri-Spike Tm Acetabular Component-K062995 (Biomet, Inc.) Device Description: The systems consist of acetabular cups, femoral heads, and adapters and inserts. The Co-Cr-Mo…
Biomet Manufacturing Corp2006—

Also cleared against K993438: 6 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc.20120
K083642Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc.20090

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 25, 2020Class IIZ-0627-2021Process controlSpecific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
  • 3 of the 47 ancestors have a recall of any class.
  • Of its descendants, K113271 (Biomet Manufacturing, Inc., 2012) has gone furthest, with 0 descendants of its own.
  • 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. 2008, 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?

K993438, K011110, K042037, K043537, K061423, K062995: 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…

Read the full statement (121 words)

K993438, K011110, K042037, K043537, K061423, K062995:

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 using other techniques.

5. Revision of previously failed total hip arthroplasty.

K002379, K003363:

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

2. Rheumatoid arthritis.

3. Correction of functional deformity.

4. Revision procedures where other treatment or devices have failed.

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

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
  • K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc. · 2012
  • K112019Bencox ID Stem, Bencox Metal Head, Bencox Bipolar CupCorentec Co., Ltd. · 2011
  • K103431Coren Total Hip SystemCorentec Co., Ltd. · 2011
  • K042841M2A/C2A Acetabular SystemBiomet, Inc. · 2004
  • K033634Epsilon Metasul 32MM Acetabular Inserts, Standard and HoodedCenterpulse Orthopedics, Inc. · 20042 recalls

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K251270Taperloc® Complete Hip StemBiomet, Inc. · 2026
  • K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

Recent decisions in KWA

The KWA category page

  • K122778Profemur Z Revision Hip StemWrightmedicaltechnologyinc · 2012
  • K121544Dynasty Biofoam ShellWrightmedicaltechnologyinc · 2012
  • K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc. · 2012
  • K113322Conserve Thin ShellWrightmedicaltechnologyinc · 2012
  • K112080Preserve Hip StemWrightmedicaltechnologyinc · 2011

https://510kreport.com/device/K082446 · printed Nov 5, 2026

Cite this page

510(k) Report. “K082446: Biomet Metal-on-Metal Hip Systems- Expanded Contraindications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082446

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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