510(k) Report

510(k) · Cleared

Cleared

Wagner Revision Stem (Modification)

K953689510(k) TraditionalCleared Nov 29, 1995121-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

Intermedics Orthopedics · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Nov 29, 1995 after a 121-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.

Decided
Nov 29, 1995
Review
121 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
0

12 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2022: 2 descendants cleared2005: 1 descendant cleared2019: 1 descendant cleared2015: 1 descendant cleared2016: 1 descendant cleared2026: 1 descendant cleared2018: 1 descendant cleared2017: 1 descendant cleared2020: 2 descendants cleared2021: 1 descendant cleared1995200020052010201520202025
  1. This deviceK953689 Wagner Revision Stem (Modification)Intermedics Orthopedics · 1995
  2. Descendant · cites it directly · 11 of its ownK043356 Wagner SL Revision Stem LateralZimmer Austin, Inc. · 2005
  3. Descendant · 2 generations on · 8 of its ownK161192 Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH · 2016
  4. Descendant · 3 generations on · 5 of its ownK170690 M-Vizion Femoral Revision SystemMedacta International S.A. · 2017
  5. Descendant · 4 generations on · 4 of its ownK191816 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2020
  6. Descendant · 5 generations on · 3 of its ownK201471 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2021

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2005: 12015: 12016: 12017: 12018: 12019: 12020: 22021: 12022: 22026: 1
2005high 2 (2020) · low 0 (2006)2026

Most influential descendants

Showing 5 of 12 · See all
  • K043356Wagner SL Revision Stem LateralZimmer Austin, Inc. · 2005 · cites it directly11descendants
  • K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH · 2016 · 2 generations on8descendants
  • K170690M-Vizion Femoral Revision SystemMedacta International S.A. · 2017 · 3 generations on5descendants
  • K191816M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2020 · 4 generations on4descendants
  • K201471M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2021 · 5 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K953689Wagner Revision Stem (Modification)Intermedics Orthopedics1995—
+1K043356Wagner SL Revision Stem LateralZimmer Austin, Inc.2005—
+2K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH2016—
+3K170690M-Vizion Femoral Revision SystemMedacta International S.A.2017—
+4K191816M-Vizion Femoral Revision System ExtensionMedacta International S.A.2020—
+5K201471M-Vizion Femoral Revision System ExtensionMedacta International S.A.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
201510
201610
201710
201810
201910
202020
202110
202220
202610
FIG. 1 — Lineage of K953689, 1995–2026Source: 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
Get a 510(k) Report

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? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K043356Wagner SL Revision Stem LateralZimmer Austin, Inc.200511
K212327M-Vizion MonoblocMedacta International S.A.20221

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?

  • Of its descendants, K043356 (Zimmer Austin, Inc., 2005) has gone furthest, with 11 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.

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 Intermedics Orthopedics

108 FDA decisions under this applicant name. See the company

  • K970300Natural-Hip System Porous Stem with HA/CstiIntermedics Orthopedics · 1997
  • K970498Natural-Knee II Revision Femoral Spacer LugsIntermedics Orthopedics · 1997
  • K970166Natural-Hip System Cocr Revision StemIntermedics Orthopedics · 1997
  • K970567Select Shoulder Curved-Back Pegged All Poly GlenoidsIntermedics Orthopedics · 1997
  • K964357Natural-Hip System Cocr StemIntermedics Orthopedics · 1997

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/K953689 · printed Nov 4, 2026

Cite this page

510(k) Report. “K953689: Wagner Revision Stem (Modification).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953689

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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