510(k) Report

510(k) · Cleared

Recalled · 2007

Howmedica Femoral & Proximal Tibial Modular Replacement Sytesm

K952970510(k) TraditionalCleared Jan 17, 1996204-day reviewClass II21 CFR 888.3350Recalls 13

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

Howmedica Corp. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Cleared on Jan 17, 1996 after a 204-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it. It has been recalled 13 times.

Decided
Jan 17, 1996
Review
204 days
Class
Class II
Product code
JDI
Recalls
13
Predicates
0

16 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2024: 1 descendant cleared1998: 1 descendant cleared2004: 1 descendant cleared2025: 2 descendants cleared2007: 1 descendant cleared2008: 1 descendant cleared2010: 1 descendant cleared2012: 2 descendants cleared2015: 1 descendant cleared2019: 1 descendant cleared2018: 1 descendant cleared2026: 1 descendant cleared2023: 1 descendant cleared1995200020052010201520202025
  1. This deviceK952970 Howmedica Femoral & Proximal Tibial Modular Replacement SytesmHowmedica Corp. · 1996
  2. Descendant · cites it directly · 11 of its ownK043547 Compress Segmental Femoral Replacement SystemBiomet, Inc. · 2005 · Recalled
  3. Descendant · 2 generations on · 10 of its ownK062998 Compress Segmental Femoral Replacement System (Short Spindle and…Biomet Manufacturing Corp · 2007 · Recalled
  4. Descendant · 3 generations on · 5 of its ownK112905 Compress (R) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC · 2012 · Recalled
  5. Descendant · 4 generations on · 2 of its ownK173411 Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp · 2018
  6. Descendant · 2 generations on · 2 of its ownK080330 Segmental Distal Femoral Components and Proximal Femoral Bodies with…Biomet, Inc. · 2008

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

1998: 12004: 12005: 12007: 12008: 12010: 12012: 22015: 12018: 12019: 12023: 12024: 12025: 22026: 1
1998high 2 (2012) · low 0 (1999)2026

Most influential descendants

Showing 5 of 16 · See all
  • K043547Compress Segmental Femoral Replacement SystemBiomet, Inc. · 2005 · cites it directly11descendants
  • K062998Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug)Biomet Manufacturing Corp · 2007 · 2 generations on10descendants
  • K112905Compress (R) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC · 2012 · 3 generations on5descendants
  • K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp · 2018 · 4 generations on2descendants
  • K080330Segmental Distal Femoral Components and Proximal Femoral Bodies with a Compress Female…Biomet, Inc. · 2008 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K952970Howmedica Femoral & Proximal Tibial Modular Replacement SytesmHowmedica Corp.1996—
+1K043547Compress Segmental Femoral Replacement SystemBiomet, Inc.20056
+2K062998Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug)Biomet Manufacturing Corp200721
+3K112905Compress (R) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC20122
+4K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp2018—
+2K080330Segmental Distal Femoral Components and Proximal Femoral Bodies with a…Biomet, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200410
200510
200710
200810
201010
201220
201510
201810
201910
202310
202410
202520
202610
FIG. 1 — Lineage of K952970, 1996–2026Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K043547Compress Segmental Femoral Replacement SystemBiomet, Inc.200511
K040749Modular Replacement System Cemented StemsHowmedica Osteonics Corp.20042
K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20240
K980813Reliance Long Stem Femoral ComponentsHowmedica, Inc.19980

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 15, 2007Not classifiedZ-0919-2008Process designCurvature Discrepancy --The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.
Nov 15, 2007Not classifiedZ-0922-2008Process designCurvature Discrepancy -- The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.
Nov 15, 2007Not classifiedZ-0927-2008Process designCurvature Discrepancy -- The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.
Nov 15, 2007Not classifiedZ-0917-2008Process designCurvature Discrepancy -- The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.
Nov 15, 2007Not classifiedZ-0918-2008Process designCurvature Discrepancy --The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.
Nov 15, 2007Not classifiedZ-0920-2008Process designCurvature Discrepancy -- The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.
Nov 15, 2007Not classifiedZ-0923-2008Process designCurvature Discrepancy -- The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.
Nov 15, 2007Not classifiedZ-0924-2008Process designCurvature Discrepancy -- The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.
Nov 15, 2007Not classifiedZ-0925-2008Process designCurvature Discrepancy -- The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.
Nov 15, 2007Not classifiedZ-0926-2008Process designCurvature Discrepancy -- The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.
Nov 15, 2007Not classifiedZ-0921-2008Process designCurvature Discrepancy -- The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.
Jan 7, 2003Not classifiedZ-0587-03OtherSome components have disassociated post-operatively resulting in additional surgery to the patient.
Jan 7, 2003Not classifiedZ-0588-03OtherSome components have disassociated post-operatively resulting in additional surgery to the patient.

The 5 latest of 13 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K043547 (Biomet, Inc., 2005) has gone furthest, with 11 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—

More from Howmedica Corp.

393 FDA decisions under this applicant name. See the company

  • N17004/S013Surgical Simplex P Bone CementHowmedica Corp. · 2000
  • N17004/S012Surgical Simplex P Radiopaque Bone CementHowmedica Corp. · 2000
  • K983528Micro Dynamic MeshHowmedica Corp. · 1998
  • K983404Type 3 Femoral ComponentsHowmedica Corp. · 19981 recall
  • K980925Duration II Tibial Inserts-Ethylene Oxide SterilizationHowmedica Corp. · 1998

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/K952970 · printed Nov 4, 2026

Cite this page

510(k) Report. “K952970: Howmedica Femoral & Proximal Tibial Modular Replacement Sytesm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952970

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026