510(k) Report

510(k) · Cleared

Cleared

Parallel-Sided Extensively Coated Femoral Stems

K073637510(k) TraditionalCleared Mar 20, 200885-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 Corp · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

Cleared on Mar 20, 2008 as substantially equivalent to K982367 (Biomet, Inc., 1998) and 2 other predicates after an 85-day review. Its family tree reaches back 4 generations to 1985.

Decided
Mar 20, 2008
Review
85 days
Class
Class III
Product code
KWA
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K854046 (1985). 23 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 2 other ancestors1998: 1 other ancestor2002: 1 other ancestor1997: 1 other ancestor1996: 2 other ancestors1994: 7 other ancestors2000: 1 other ancestor1999: 2 other ancestors1995: 1 other ancestor1986: 1 other ancestorK854046 · Conical Collar Hip Prosthesis · Kirschner Medical Corp. · 1985K960303 · Fenning Femoral Component · Biomet, Inc. · 1996K030055 · Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral Components · Biomet, Inc. · 2003 · recalledK052089 · XR-Series BI-Metric Femoral Components · Biomet Manufacturing, Inc. · 2006198519901995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 9 other ancestors3 generations back: 4 other ancestors4 generations back: 4 other ancestors K052089 · XR-Series BI-Metric Femoral Components · Biomet Manufacturing, Inc. · 2006K030055 · Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral Components · Biomet, Inc. · 2003 · recalledK960303 · Fenning Femoral Component · Biomet, Inc. · 1996K854046 · Conical Collar Hip Prosthesis · Kirschner Medical Corp. · 19850
  1. Root · 4 generations backK854046 Conical Collar Hip ProsthesisKirschner Medical Corp. · 1985
  2. 3 generations backK960303 Fenning Femoral ComponentBiomet, Inc. · 1996
  3. 2 generations backK030055 Mallory/Head Total Hip System; HA Mallory/Head Total Hip System…Biomet, Inc. · 2003 · Recalled
  4. 1 generation backK052089 XR-Series BI-Metric Femoral ComponentsBiomet Manufacturing, Inc. · 2006
  5. This deviceK073637 Parallel-Sided Extensively Coated Femoral StemsBiomet Manufacturing Corp · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K854046Conical Collar Hip ProsthesisKirschner Medical Corp.1985—
−3K960303Fenning Femoral ComponentBiomet, Inc.1996—
−2K030055Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric…Biomet, Inc.20033
−1K052089XR-Series BI-Metric Femoral ComponentsBiomet Manufacturing, Inc.2006—
0 (this device)K073637Parallel-Sided Extensively Coated Femoral StemsBiomet Manufacturing Corp2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199470
199510
199620
199710
199810
199920
200010
200120
200210
FIG. 1 — Lineage of K073637, 1985–2008Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K982367Reach Hip Component
Summary page 1
…p, Hem!-, Femoral, Metal/Polymer, Cemented or Uncemented (888.3390) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Reach® Revision System- K982367, 08/24/98 (Bioniet Inc.) AML® Hip Stem- K012364, 10/19/01 (DePuy Inc.) XR-Series Bi-Metric® Femoral Stems- K05208…
Biomet, Inc.1998—
*K012364Aml Hip Prosthesis
Summary page 1
…(888.3390) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Reach® Revision System- K982367, 08/24/98 (Bioniet Inc.) AML® Hip Stem- K012364, 10/19/01 (DePuy Inc.) XR-Series Bi-Metric® Femoral Stems- K052089, 02/17/06 (Biomet Inc.) Device Description: Th…
DePuy Orthopaedics, Inc.2001—
*K052089XR-Series BI-Metric Femoral Components
Summary page 1
…aimed: Reach® Revision System- K982367, 08/24/98 (Bioniet Inc.) AML® Hip Stem- K012364, 10/19/01 (DePuy Inc.) XR-Series Bi-Metric® Femoral Stems- K052089, 02/17/06 (Biomet Inc.) Device Description: The Parallel-Sided Extensively Coated Femoral Stem is designed to replace the…
Biomet Manufacturing, Inc.2006—

Also cleared against K982367: 1 other device →

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 23 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
  • 2 of the 23 ancestors have a recall of any class.
  • 1 other device also cites its predicate K982367.

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?

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 of previous failed total hip arthroplasty.

The Parallel-Sided Extensively Coated Femoral Stems are for uncemented applications only.

Indications for use as stated in the FDA summary.

Also cleared against K982367

1 other device cites the same predicate.

  • K030055Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral ComponentsBiomet, Inc. · 20033 recalls

More from Biomet Manufacturing Corp

201 FDA decisions under this applicant name. See the company

  • P010014/S119Cementless Oxford Partial Knee SystemBiomet Manufacturing Corp · 2026
  • P010014/S118Oxford Partial Knee Anatomic Vivacit-E Meniscal BearingsBiomet Manufacturing Corp · 2026
  • P010014/S117Oxford™ Partial Knee SystemBiomet Manufacturing Corp · 2026
  • P010014/S112Oxford Partial Knee System; Cementless Oxford™Partial Knee SystemBiomet Manufacturing Corp · 2026
  • P010014/S116Oxford® Partial Knee SystemBiomet Manufacturing Corp · 2026

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/K073637 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073637: Parallel-Sided Extensively Coated Femoral Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073637

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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