510(k) Report

510(k) · Cleared

Cleared

Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement Spacer

K052639510(k) TraditionalCleared May 3, 2006219-day reviewClass II21 CFR 888.3350

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

Biomet Manufacturing, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Cleared on May 3, 2006 as substantially equivalent to K031734 (Biomet, Inc., 2003) and 2 other predicates after a 219-day review. Its family tree reaches back 2 generations to 2002. 11 later devices descend from it.

Decided
May 3, 2006
Review
219 days
Class
Class II
Product code
JDI
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K023085 (2002). 3 ancestors in all, the oldest K942028 (1994). 11 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor2013: 1 descendant cleared2014: 1 descendant cleared2018: 1 descendant cleared2020: 1 descendant cleared2019: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant cleared2024: 1 descendant cleared2022: 1 descendant cleared2025: 2 descendants clearedK023085 · RX 90 Femoral Stem and RX 90 Lateralized Femoral Stem · Biomet Orthopedics, Inc. · 2002K031734 · Generation 4 Polished Femoral Hip Prosthesis · Biomet, Inc. · 20031990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 4 descendants4 generations forward: 4 descendants K031734 · Generation 4 Polished Femoral Hip Prosthesis · Biomet, Inc. · 2003K023085 · RX 90 Femoral Stem and RX 90 Lateralized Femoral Stem · Biomet Orthopedics, Inc. · 20020
  1. Root · 2 generations backK023085 RX 90 Femoral Stem and RX 90 Lateralized Femoral StemBiomet Orthopedics, Inc. · 2002
  2. 1 generation backK031734 Generation 4 Polished Femoral Hip ProsthesisBiomet, Inc. · 2003
  3. This deviceK052639 Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement…Biomet Manufacturing, Inc. · 2006
  4. Descendant · cites it directly · 10 of its ownK130610 Sirius Femoral StemBiomet, Inc. · 2013 · Recalled
  5. Descendant · 2 generations on · 9 of its ownK142295 Sirius Femoral Stem, Size 30ABiomet, Inc. · 2014
  6. Descendant · 2 generations on · 8 of its ownK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
  7. Descendant · 3 generations on · 6 of its ownK193429 Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020 · Recalled
  8. Descendant · 4 generations on · 5 of its ownK213701 Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2022

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2013: 12014: 12018: 12019: 12020: 12022: 12023: 12024: 12025: 22026: 1
2013high 2 (2025) · low 0 (2015)2026

Most influential descendants

Showing 5 of 11 · See all
  • K130610Sirius Femoral StemBiomet, Inc. · 2013 · cites it directly10descendants
  • K142295Sirius Femoral Stem, Size 30ABiomet, Inc. · 2014 · 2 generations on9descendants
  • K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · 2 generations on8descendants
  • K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020 · 3 generations on6descendants
  • K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2022 · 4 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K023085RX 90 Femoral Stem and RX 90 Lateralized Femoral StemBiomet Orthopedics, Inc.2002—
−1K031734Generation 4 Polished Femoral Hip ProsthesisBiomet, Inc.2003—
0 (this device)K052639Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement SpacerBiomet Manufacturing, Inc.2006—
+1K130610Sirius Femoral StemBiomet, Inc.20132
+2K142295Sirius Femoral Stem, Size 30ABiomet, Inc.2014—
+2K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics20182
+3K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.20201
+4K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201410
201810
201910
202010
202210
202310
202410
202520
202610
FIG. 1 — Lineage of K052639, 2002–2026Source: 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 JDI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JDI device

  1. #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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
*K031734Generation 4 Polished Femoral Hip Prosthesis
Summary page 2
…Page 2 of 3 Legally Marketed Devices > Generation 4® Polished Femoral Hip Prosthesis - Biornet to Which Substantial Manufacturing Corp. (K<031734) Equivalence Is Claimed: > Rx-90TM Femoral Stems and Lateralized Stems - Biomet Manufacturing Cor…
Biomet, Inc.2003—
*K023085RX 90 Femoral Stem and RX 90 Lateralized Femoral Stem
Summary page 2
…Manufacturing Corp. (K<031734) Equivalence Is Claimed: > Rx-90TM Femoral Stems and Lateralized Stems - Biomet Manufacturing Corp. (K<023085) > Rx-90~m Femoral Component - Biomret, Inc. (K942028) Device Description: The Generation 4® Po…
Biomet Orthopedics, Inc.2002—
*K942028RX90 Femoral Component
Summary page 2
…Stems and Lateralized Stems - Biomet Manufacturing Corp. (K<023085) > Rx-90~m Femoral Component - Biomret, Inc. (K942028) Device Description: The Generation 4® Polished Femoral Hip Prosthesis with Proximal Cement Spa…
Biomet, Inc.1994—

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K130610Sirius Femoral StemBiomet, Inc.201310

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 4 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K130610 (Biomet, Inc., 2013) has gone furthest, with 10 descendants of its own.

How does its category compare?

All JDI devices

JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDI

1in 2025

2007: 32008: 52009: 32011: 22012: 42013: 32014: 32015: 32016: 42017: 12018: 12019: 22020: 72021: 32022: 32023: 22024: 32025: 12026 (partial year): 2
2007high 7 (2020) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDI

59in 2024

2007: 81 days median2008: 96 days median2009: 65 days median2012: 167 days median2013: 176 days median2014: 98 days median2015: 190 days median2016: 166 days median2020: 247 days median2021: 162 days median2022: 69 days median2024: 59 days median
2007high 247 (2020) · low 59 (2024)2026

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

Recalls per year · JDI

1in 2025

2007: 262008: 62009: 32010: 32011: 52012: 42013: 112014: 32015: 12016: 52017: 52018: 12019: 12020: 772025: 1
2007high 77 (2020) · low 0 (2021)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JDI

1,644in 2025

2007: 6962008: 8102009: 9642010: 2,0402011: 3,1602012: 5,1222013: 5,2062014: 4,9682015: 4,9062016: 3,9952017: 6,1352018: 6,7282019: 7,4072020: 4,0152021: 3,1702022: 1,9782023: 1,6352024: 1,8212025: 1,644
2007high 7,407 (2019) · low 696 (2007)2025

MAUDE reports naming product code JDI, 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
200738126696
20085966810
20093653964
20100—32,040
20112—53,160
2012416745,122
20133176115,206
201439834,968
2015319014,906
2016416653,995
20171—56,135
20181—16,728
20192—17,407
20207247774,015
2021316203,170
202236901,978
20232—01,635
202435901,821
20251—11,644
20262—0—

What is it indicated for?

The indications for use for the Generation 4® Polished Femoral Hip Prosthesis with Proximal Cement Spacer include:

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 using other techniques.

5. Revision of previously failed total hip arthroplasty.

The Generation 4® Polished Femoral Hip Prosthesis with Proximal Cement Spacer is intended for cemented use only and may be used in partial and total hip arthroplasties.

Indications for use as stated in the FDA summary.

More from Biomet Manufacturing, Inc.

32 FDA decisions under this applicant name. See the company

  • K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc. · 20131 recall
  • K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc. · 2012
  • 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

Recent decisions in JDI

The JDI category page

  • K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc. · 2026
  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer Biomet · 2025
  • K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip…Smith & Nephew, Inc. · 2024
  • K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024

https://510kreport.com/device/K052639 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052639: Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052639

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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