510(k) Report

510(k) · Cleared

Cleared

Zimmer M/L Taper Hip Prosthesis

K192660510(k) TraditionalCleared Feb 28, 2020156-day reviewClass II21 CFR 888.3353

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 Feb 28, 2020 as substantially equivalent to K032726 (Zimmer, Inc., 2003) and 2 other predicates after a 156-day review. Its family tree reaches back 7 generations to 1985. 2 later devices descend from it.

Decided
Feb 28, 2020
Review
156 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
3

Its longest line of descent runs back 7 generations to K850055 (1985). 23 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2002: 1 other ancestor1997: 2 other ancestors1994: 6 other ancestors1996: 3 other ancestors1990: 1 other ancestor1987: 1 other ancestor2020: 1 descendant cleared2025: 1 descendant clearedK850055 · Profile Femoral Hip · Depuy, Inc. · 1985K961378 · Delta Hip Prosthesis · Zimmer, Inc. · 1996 · recalled×2: 2 generations cleared close together, K992667 (1999), K994286 (2000) K032726 · Zimmer M/L Taper Hip Prosthesis, 7711 Series · Zimmer, Inc. · 2003 · recalledK042337 · Zimmer M/L Taper Hip Prosthesis with Calcicoat Ceramic Coating · Zimmer, Inc. · 2004K060040 · Zimmer M/L Taper Hip Prosthesis · Zimmer, Inc. · 2006 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 5 other ancestors3 generations back: 8 other ancestors4 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K060040 · Zimmer M/L Taper Hip Prosthesis · Zimmer, Inc. · 2006 · recalledK042337 · Zimmer M/L Taper Hip Prosthesis with Calcicoat Ceramic Coating · Zimmer, Inc. · 2004K032726 · Zimmer M/L Taper Hip Prosthesis, 7711 Series · Zimmer, Inc. · 2003 · recalledK994286 · ZMR Hip System-Porous Revision · Zimmer, Inc. · 2000 · recalledK992667 · ZMR Hip System-Revision Taper · Zimmer, Inc. · 1999 · recalledK961378 · Delta Hip Prosthesis · Zimmer, Inc. · 1996 · recalledK850055 · Profile Femoral Hip · Depuy, Inc. · 1985−50
  1. Root · 7 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
  2. 6 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
  3. 5 generations backK992667 ZMR Hip System-Revision TaperZimmer, Inc. · 1999 · Recalled
  4. 4 generations backK994286 ZMR Hip System-Porous RevisionZimmer, Inc. · 2000 · Recalled
  5. 3 generations backK032726 Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. · 2003 · Recalled
  6. 2 generations backK042337 Zimmer M/L Taper Hip Prosthesis with Calcicoat Ceramic CoatingZimmer, Inc. · 2004
  7. 1 generation backK060040 Zimmer M/L Taper Hip ProsthesisZimmer, Inc. · 2006 · Recalled
  8. This deviceK192660 Zimmer M/L Taper Hip ProsthesisZimmer, Inc. · 2020
  9. Descendant · cites it directly · 1 of its ownK200823 Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc. · 2020 · Recalled
  10. Descendant · 2 generations on · 0 of its ownK250834 Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet · 2025

Most influential descendants

Showing 2 of 2 · See all
  • K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc. · 2020 · cites it directly1descendant
  • K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet · 2025 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K850055Profile Femoral HipDepuy, Inc.1985—
−6K961378Delta Hip ProsthesisZimmer, Inc.19964
−5K992667ZMR Hip System-Revision TaperZimmer, Inc.19991
−4K994286ZMR Hip System-Porous RevisionZimmer, Inc.200011
−3K032726Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc.20033
−2K042337Zimmer M/L Taper Hip Prosthesis with Calcicoat Ceramic CoatingZimmer, Inc.2004—
−1K060040Zimmer M/L Taper Hip ProsthesisZimmer, Inc.20062
0 (this device)K192660Zimmer M/L Taper Hip ProsthesisZimmer, Inc.2020—
+1K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.20201
+2K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199010
199460
199630
199720
200210
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202510
FIG. 1 — Lineage of K192660, 1985–2025Source: 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 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
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
*K032726Zimmer M/L Taper Hip Prosthesis, 7711 Series
Summary page 4
…Uncemented, Metal/Polymer, Non-Porous, Calcium- Phosphate (21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis) K032726 ZIMMER M/L Zimmer, Inc TAPER HIP PROSTHESIS, 7711 SERIES K042337 ZIMMER M/L Zimmer, Inc TAPER HIP PROSTHESIS WITH CALCICOAT CERAM…
Zimmer, Inc.20033
*K042337Zimmer M/L Taper Hip Prosthesis with Calcicoat Ceramic Coating
Summary page 4
…888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis) K032726 ZIMMER M/L Zimmer, Inc TAPER HIP PROSTHESIS, 7711 SERIES K042337 ZIMMER M/L Zimmer, Inc TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING K060040 ZIMMER M/L Zimmer, Inc Device…
Zimmer, Inc.2004—
*K060040Zimmer M/L Taper Hip Prosthesis
Summary page 4
…cemented prosthesis) K032726 ZIMMER M/L Zimmer, Inc TAPER HIP PROSTHESIS, 7711 SERIES K042337 ZIMMER M/L Zimmer, Inc TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING K060040 ZIMMER M/L Zimmer, Inc Device Description Indications for Use: Summary of Technological Characteristics: TAPER…
Zimmer, Inc.20062

Also cleared against K032726: 6 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.20201

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 35 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
  • 12 of the 22 ancestors have a recall of any class.
  • Of its descendants, K200823 (Zimmer, Inc., 2020) has gone furthest, with 1 descendant of its own.
  • 6 other devices also cite its predicate K032726.

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. 2020, 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—

What is it indicated for?

Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected…

Read the full statement (141 words)

Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.

Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

The femoral stem is for cementless use only.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K032726

6 other devices cite the same predicate.

  • K163577Ecofit® Hip SystemImplantcast GmbH · 20171 recall
  • K161830Zimmer M/L Taper Hip ProsthesisZimmer, Inc. · 2016
  • K071723Zimmer Porolock Mis StemZimmer GmbH · 20082 recalls
  • K063251Zimmer M/L Taper Hip Prosthesis with Modular Neck TechnologyZimmer, Inc. · 20074 recalls
  • K060040Zimmer M/L Taper Hip ProsthesisZimmer, Inc. · 20062 recalls
  • K042337Zimmer M/L Taper Hip Prosthesis with Calcicoat Ceramic CoatingZimmer, Inc. · 2004

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/K192660 · printed Nov 6, 2026

Cite this page

510(k) Report. “K192660: Zimmer M/L Taper Hip Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192660

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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