510(k) Report

510(k) · Cleared

Cleared

Porous Titanium Acetabular Augments

K052888510(k) TraditionalCleared Dec 6, 200554-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 Dec 6, 2005 as substantially equivalent to K001471 (Implex Corp., 2000) after a 54-day review. Its family tree reaches back 1 generation to 2000. 54 later devices descend from it.

Decided
Dec 6, 2005
Review
54 days
Class
Class III
Product code
KWA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K001471 (2000). 54 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2018: 4 descendants cleared2013: 1 descendant cleared2024: 8 descendants cleared2015: 1 descendant cleared2022: 3 descendants cleared2025: 12 descendants cleared2019: 2 descendants cleared2016: 1 descendant cleared2020: 8 descendants cleared2017: 1 descendant cleared2021: 2 descendants cleared2023: 4 descendants cleared2026: 6 descendants clearedK001471 · The Implex Hedrocel Acetabular Augment, XX-Yyy-ZZZZ · Implex Corp. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 5 descendants3 generations forward: 12 descendants4 generations forward: 20 descendants5 generations forward: 12 descendants6 generations forward: 4 descendants K001471 · The Implex Hedrocel Acetabular Augment, XX-Yyy-ZZZZ · Implex Corp. · 20000+5
  1. Root · 1 generation backK001471 The Implex Hedrocel Acetabular Augment, XX-Yyy-ZZZZImplex Corp. · 2000
  2. This deviceK052888 Porous Titanium Acetabular AugmentsBiomet Manufacturing Corp · 2005
  3. Descendant · cites it directly · 53 of its ownK100391 Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc. · 2010
  4. Descendant · 2 generations on · 40 of its ownK143393 Triathlon Tritanium Cone AugmentsStryker Orthopaedics · 2015 · Recalled
  5. Descendant · 3 generations on · 24 of its ownK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
  6. Descendant · 4 generations on · 14 of its ownK173849 Triathlon Total Knee SystemStryker Orthopaedics · 2018 · Recalled
  7. Descendant · 4 generations on · 11 of its ownK190402 Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019

Showing 5 of 54 descendants. See all descendants

Descendants cleared per year

2010: 12013: 12015: 12016: 12017: 12018: 42019: 22020: 82021: 22022: 32023: 42024: 82025: 122026: 6
2010high 12 (2025) · low 0 (2011)2026

Most influential descendants

Showing 5 of 54 · See all
  • K100391Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc. · 2010 · cites it directly53descendants
  • K143393Triathlon Tritanium Cone AugmentsStryker Orthopaedics · 2015 · 2 generations on40descendants
  • K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 2017 · 3 generations on24descendants
  • K173849Triathlon Total Knee SystemStryker Orthopaedics · 2018 · 4 generations on14descendants
  • K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019 · 4 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K001471The Implex Hedrocel Acetabular Augment, XX-Yyy-ZZZZImplex Corp.2000—
0 (this device)K052888Porous Titanium Acetabular AugmentsBiomet Manufacturing Corp2005—
+1K100391Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc.2010—
+2K143393Triathlon Tritanium Cone AugmentsStryker Orthopaedics20151
+3K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics20171
+4K173849Triathlon Total Knee SystemStryker Orthopaedics20183
+4K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.)2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201310
201510
201610
201710
201840
201920
202080
202120
202230
202340
202480
2025120
202660
FIG. 1 — Lineage of K052888, 2000–2026Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K001471The Implex Hedrocel Acetabular Augment, XX-Yyy-ZZZZ
Summary page 1
…-constrained cemented or non porous uncemented prosthesis (888.3353) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Hedrocel® Acetabular Augment (K001471) Device Description: The acetabular augments are constructed of porous titanium alloy conforming to ASTM F 1580-95. The augments…
Implex Corp.2000—

Also cleared against K001471: 1 other device →

What descends from it? (54)

See all 54

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K100391Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc.201053

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?

  • Its one ancestor has no recall.
  • Of its descendants, K100391 (DePuy Orthopaedics, Inc., 2010) has gone furthest, with 53 descendants of its own.
  • 1 other device also cites its predicate K001471.

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.

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?

The Porous Titanium Acetabular Augments are indicated for cemented or non-cemented use in cases of: 1. Noninflammatory 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 using other techniques. 5. Revision of previously failed total…

Read the full statement (133 words)

The Porous Titanium Acetabular Augments are indicated for cemented or non-cemented use in cases of:

1. Noninflammatory 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 using other techniques.

5. Revision of previously failed total hip arthroplasty.

The porous titanium augments are intended to provide the orthopedic surgeon with a prosthetic alternative to structural allograft in cases of segmental deficiencies.

The porous titanium acetabular augment is affixed to the mating acetabular cup using bone cement. The assembled porous titanium augment/acetabular construct is intended for cemented or uncemented use.

The porous titanium acetabular augments are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery.

Indications for use as stated in the FDA summary.

Also cleared against K001471

1 other device cites the same predicate.

  • K061067Trabecular Metal Acetabular AugmentsZimmer Trabecular · 20064 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/K052888 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052888: Porous Titanium Acetabular Augments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052888

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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