510(k) Report

510(k) · Cleared

Cleared

CLS Stem, Wagner Revision Stem, Alloclassic Zweymuller Stem, SL

K973837510(k) TraditionalCleared Jan 6, 199890-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

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

Cleared on Jan 6, 1998 after a 90-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.

Decided
Jan 6, 1998
Review
90 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2019: 1 descendant cleared2026: 1 descendant cleared1995200020052010201520202025
  1. This deviceK973837 CLS Stem, Wagner Revision Stem, Alloclassic Zweymuller Stem, SLSulzer Orthopedics, Inc. · 1998
  2. Descendant · cites it directly · 1 of its ownK183141 LINK MP Monoblock Hip ProsthesisWaldemar Link GmbH & Co. KG · 2019 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK260173 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026

Most influential descendants

Showing 2 of 2 · See all
  • K183141LINK MP Monoblock Hip ProsthesisWaldemar Link GmbH & Co. KG · 2019 · cites it directly1descendant
  • K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K973837CLS Stem, Wagner Revision Stem, Alloclassic Zweymuller Stem, SLSulzer Orthopedics, Inc.1998—
+1K183141LINK MP Monoblock Hip ProsthesisWaldemar Link GmbH & Co. KG201912
+2K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202610
FIG. 1 — Lineage of K973837, 1998–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (2)

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
*—APR System
Named without a submission number
—
*—Natural Hip System
Named without a submission number
—

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K183141LINK MP Monoblock Hip ProsthesisWaldemar Link GmbH & Co. KG20191

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, K183141 (Waldemar Link GmbH & Co. KG, 2019) has gone furthest, with 1 descendant 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—

What is it indicated for?

The CLS, Wagner Revision and AlloClassic Zweymuller femoral stems will be used in conjunction with the Zirconia Ceramic Total Head. This stem/head combination is intended for prosthetic replacement of the proximal portion of the femur during total hip arthroplasty in which the ball head articulates with a polyethylene acetabular component. Specific diagnostic indications include: Patient conditions of inflammatory degenerative joint disease (e.g.…

Read the full statement (111 words)

The CLS, Wagner Revision and AlloClassic Zweymuller femoral stems will be used in conjunction with the Zirconia Ceramic Total Head. This stem/head combination is intended for prosthetic replacement of the proximal portion of the femur during total hip arthroplasty in which the ball head articulates with a polyethylene acetabular component. Specific diagnostic indications include:

Patient conditions of inflammatory degenerative joint disease (e.g., rheumatoid arthritis) and noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis);

Those patients with failed previous surgery where pain, deformity, or dysfunction persist; and,

Revision of previously failed hip arthroplasty.

The CLS Stem, Wagner Revision Stem and AlloClassic Zweymuller Stem are intended for use with or without bone cement.

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

More from Sulzer Orthopedics, Inc.

45 FDA decisions under this applicant name. See the company

  • K022985Ascendent Acetabular SystemSulzer Orthopedics, Inc. · 20021 recall
  • K021578Natural-Knee II System Cocr Tibial BaseplateSulzer Orthopedics, Inc. · 2002
  • K020713MS-30 Lateral Femoral StemSulzer Orthopedics, Inc. · 20021 recall
  • K013935Allofit Acetabular System 32MM Alpha Durasul InsertsSulzer Orthopedics, Inc. · 2001
  • K013031Most Options SystemSulzer Orthopedics, Inc. · 20013 recalls

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/K973837 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973837: CLS Stem, Wagner Revision Stem, Alloclassic Zweymuller Stem, SL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973837

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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