510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Zimmer Segmental System Proximal Femoral Component and Small Diameter Stem Extensions

K101296510(k) TraditionalCleared Jul 30, 201081-day reviewClass II21 CFR 888.3353Recalls 2

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

Zimmer, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Jul 30, 2010 after an 81-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it. It has been recalled 2 times.

Decided
Jul 30, 2010
Review
81 days
Class
Class II
Product code
LZO
Recalls
2
Predicates
0

11 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2019: 2 descendants cleared2020: 1 descendant cleared2014: 1 descendant cleared2025: 3 descendants cleared2015: 2 descendants cleared2026: 1 descendant cleared2010201520202025
  1. This deviceK101296 Zimmer Segmental System Proximal Femoral Component and Small…Zimmer, Inc. · 2010
  2. Descendant · cites it directly · 10 of its ownK110940 Zimmer Segment System Trabecular Metal Proximal Tibial Component…Zimmer, Inc. · 2011
  3. Descendant · 2 generations on · 3 of its ownK141331 Biomet Orthopaedic Salvage System (Oss)Biomet, Inc. · 2014
  4. Descendant · 2 generations on · 2 of its ownK190100 USTAR II SystemUnited Orthopedic Corporation · 2019 · Recalled
  5. Descendant · cites it directly · 1 of its ownK183136 Zimmer Segmental System Proximal Femoral ComponentZimmer, Inc. · 2019
  6. Descendant · 3 generations on · 1 of its ownK142814 Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral &…Biomet Manufacturing, LLC · 2015 · Recalled

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2011: 12014: 12015: 22019: 22020: 12025: 32026: 1
2011high 3 (2025) · low 0 (2012)2026

Most influential descendants

Showing 5 of 11 · See all
  • K110940Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal…Zimmer, Inc. · 2011 · cites it directly10descendants
  • K141331Biomet Orthopaedic Salvage System (Oss)Biomet, Inc. · 2014 · 2 generations on3descendants
  • K190100USTAR II SystemUnited Orthopedic Corporation · 2019 · 2 generations on2descendants
  • K183136Zimmer Segmental System Proximal Femoral ComponentZimmer, Inc. · 2019 · cites it directly1descendant
  • K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC · 2015 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K101296Zimmer Segmental System Proximal Femoral Component and Small Diameter Stem…Zimmer, Inc.2010—
+1K110940Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular…Zimmer, Inc.2011—
+2K141331Biomet Orthopaedic Salvage System (Oss)Biomet, Inc.2014—
+2K190100USTAR II SystemUnited Orthopedic Corporation20195
+1K183136Zimmer Segmental System Proximal Femoral ComponentZimmer, Inc.2019—
+3K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC20156

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201410
201520
201920
202010
202530
202610
FIG. 1 — Lineage of K101296, 2010–2026Source: 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 LZO? 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 LZO device

  1. #1 K192827 Quadra-Pscore 19.3 · 10 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? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K110940Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal…Zimmer, Inc.201110
K183136Zimmer Segmental System Proximal Femoral ComponentZimmer, Inc.20191
K192798Zimmer Segmental SystemZimmer, Inc.20200

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 29, 2018Class IIZ-1381-2018Under Investigation by firmThere is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent cleaning process.
Feb 5, 2015Class IIZ-1219-2015Process controlPMMA coating does not meet specifications. Area of the stem may be missing PMMA coating.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K110940 (Zimmer, Inc., 2011) has gone furthest, with 10 descendants of its own.

How does its category compare?

All LZO devices

LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · LZO

14in 2025

2007: 92008: 112009: 72010: 152011: 132012: 142013: 262014: 132015: 122016: 102017: 162018: 182019: 282020: 182021: 122022: 112023: 102024: 112025: 142026 (partial year): 9
2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007: 87 days median2008: 63 days median2009: 83 days median2010: 78 days median2011: 87 days median2012: 98 days median2013: 100 days median2014: 85 days median2015: 115 days median2016: 177 days median2017: 257 days median2018: 163 days median2019: 109 days median2020: 112 days median2021: 170 days median2022: 279 days median2023: 122 days median2024: 111 days median2025: 119 days median2026 (partial year): 102 days median
2007high 279 (2022) · low 63 (2008)2026

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

Recalls per year · LZO

1in 2025

2007: 22008: 132009: 422011: 102012: 142014: 12015: 12016: 92017: 52018: 22019: 42020: 32022: 42023: 22024: 12025: 1
2007high 42 (2009) · low 0 (2010)2026

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

Adverse event reports per year · LZO

3,244in 2025

2007: 1382008: 1252009: 1892010: 3942011: 5442012: 9632013: 1,3702014: 1,4772015: 1,3482016: 1,7282017: 2,1652018: 3,1332019: 3,0662020: 1,9632021: 2,1992022: 1,9852023: 2,0662024: 2,5862025: 3,244
2007high 3,244 (2025) · low 125 (2008)2025

MAUDE reports naming product code LZO, 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
20079872138
2008116313125
200978342189
201015780394
2011138710544
2012149814963
20132610001,370
2014138511,477
20151211511,348
20161017791,728
20171625752,165
20181816323,133
20192810943,066
20201811231,963
20211217002,199
20221127941,985
20231012222,066
20241111112,586
20251411913,244
202691020—

More from Zimmer, Inc.

524 FDA decisions under this applicant name. See the company

  • P060037/S100NexGen® LPS-Flex/LPS Mobile Bearing Knee SystemZimmer, Inc. · 2026
  • P060037/S099NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee SystemZimmer, Inc. · 2026
  • K262955OsseoFit Stemless Shoulder SystemZimmer, Inc. · 2026
  • P060037/S097Creep Pressure Test Update for the Nexgen LPS Bearing KneeZimmer, Inc. · 2026
  • P060037/S098Nexgen LPS Femoral and Tibial Knee componentsZimmer, Inc. · 2026

Recent decisions in LZO

The LZO category page

  • K262473NEXUS® Hip StemMicroport Orthopedics, Inc. · 2026
  • K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
  • K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
  • K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG · 2026
  • K260831Z1 Hip SystemZimmer, Inc. · 2026

https://510kreport.com/device/K101296 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101296: Zimmer Segmental System Proximal Femoral Component and Small Diameter Stem Extensions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101296

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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