510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Modification to Alloclassic Zweymuller SL Offset Femoral Stem

K033664510(k) SpecialCleared Dec 17, 200326-day reviewClass II21 CFR 888.3353Recalls 1

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

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

Cleared on Dec 17, 2003 as substantially equivalent to K030373 (Centerpulse Orthopedics, Inc., 2003) after a 26-day review. Its family tree reaches back 3 generations to 1987. 8 later devices descend from it. It has been recalled once.

Decided
Dec 17, 2003
Review
26 days
Class
Class II
Product code
LZO
Recalls
1
Predicates
1

Its longest line of descent runs back 3 generations to K871453 (1987). 4 ancestors in all. 8 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor2005: 1 descendant cleared2014: 2 descendants cleared2017: 2 descendants cleared2019: 1 descendant cleared2015: 1 descendant cleared2020: 1 descendant clearedK871453 · Zweymueller-SL Hip Prosthesis Stem · Allo Pro Corp. · 1987K962101 · Zweymueller SL Femoral Hip Stem · Intermedics Orthopedics · 1996K030373 · Alloclassic Zweymueller SL/SLL Femoral Stem · Centerpulse Orthopedics, Inc. · 2003 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant K030373 · Alloclassic Zweymueller SL/SLL Femoral Stem · Centerpulse Orthopedics, Inc. · 2003 · recalledK962101 · Zweymueller SL Femoral Hip Stem · Intermedics Orthopedics · 1996K871453 · Zweymueller-SL Hip Prosthesis Stem · Allo Pro Corp. · 19870
  1. Root · 3 generations backK871453 Zweymueller-SL Hip Prosthesis StemAllo Pro Corp. · 1987
  2. 2 generations backK962101 Zweymueller SL Femoral Hip StemIntermedics Orthopedics · 1996
  3. 1 generation backK030373 Alloclassic Zweymueller SL/SLL Femoral StemCenterpulse Orthopedics, Inc. · 2003 · Recalled
  4. This deviceK033664 Modification to Alloclassic Zweymuller SL Offset Femoral StemCenterpulse Orthopedics, Inc. · 2003
  5. Descendant · cites it directly · 2 of its ownK133832 Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc. · 2014
  6. Descendant · cites it directly · 2 of its ownK131454 Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc. · 2014
  7. Descendant · cites it directly · 1 of its ownK193050 Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL…Zimmer GmbH · 2019
  8. Descendant · 2 generations on · 1 of its ownK151440 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2015
  9. Descendant · 2 generations on · 0 of its ownK200112 Zimmer Hip Joint ReplacementZimmer GmbH · 2020 · Recalled

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2005: 12014: 22015: 12017: 22019: 12020: 1
2005high 2 (2014) · low 0 (2006)2026

Most influential descendants

Showing 5 of 8 · See all
  • K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc. · 2014 · cites it directly2descendants
  • K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc. · 2014 · cites it directly2descendants
  • K193050Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral StemZimmer GmbH · 2019 · cites it directly1descendant
  • K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2015 · 2 generations on1descendant
  • K200112Zimmer Hip Joint ReplacementZimmer GmbH · 2020 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K871453Zweymueller-SL Hip Prosthesis StemAllo Pro Corp.1987—
−2K962101Zweymueller SL Femoral Hip StemIntermedics Orthopedics1996—
−1K030373Alloclassic Zweymueller SL/SLL Femoral StemCenterpulse Orthopedics, Inc.20031
0 (this device)K033664Modification to Alloclassic Zweymuller SL Offset Femoral StemCenterpulse Orthopedics, Inc.2003—
+1K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.2014—
+1K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.2014—
+1K193050Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset…Zimmer GmbH2019—
+2K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.2015—
+2K200112Zimmer Hip Joint ReplacementZimmer GmbH20202

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
201420
201510
201720
201910
202010
FIG. 1 — Lineage of K033664, 1987–2020Source: 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? (1)

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
*K030373Alloclassic Zweymueller SL/SLL Femoral Stem
Summary page 2
…terpulse Orthopedics believes the Alloclassic Zweymiiller SL Offset Femoral Stem is substantially equivalent to the previously cleared, Zweymibller SL Femoral Stem (ref. K030373 as Exhibit 3) as it has the same indications for use, basic design, sizes, material, sterilization method, and method of manufact…
Centerpulse Orthopedics, Inc.20031

Also cleared against K030373: 8 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142
K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142
K193050Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral StemZimmer GmbH20191
K170473C2 femoral stemLima Corporate S.P.A.20170
K051826Betacone Hip Prosthesis SystemWaldemar Link GmbH & Co. KG20050

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 4, 2012Class IIZ-0214-2013Error in labelingZimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K133832 (Total Joint Orthopedics, Inc., 2014) has gone furthest, with 2 descendants of its own.
  • 8 other devices also cite its predicate K030373.

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 Alloclassic SL Offset Femoral Stem is intended for prosthetic replacement without bone cement in treatment of the following:

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

* those patients with failed previous surgery where pain, deformity, or dysfunction persists.

* revision of a previously failed hip arthroplasty.

* patients who require a total hip replacement.

Indications for use as stated in the FDA summary.

Also cleared against K030373

8 other devices cite the same predicate.

  • K193050Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral StemZimmer GmbH · 2019
  • K170473C2 femoral stemLima Corporate S.P.A. · 2017
  • K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010
  • K071723Zimmer Porolock Mis StemZimmer GmbH · 20082 recalls
  • K051223Hipstar Femoral StemStryker Orthopaedics · 20061 recall
  • K052275Smith & Nephew Platform Hip StemSmith & Nephew, Inc. · 2005

More from Centerpulse Orthopedics, Inc.

10 FDA decisions under this applicant name. See the company

  • K033943Alpha Metasul 28MM and 32MM Acetabular Inserts, Standard and HoodedCenterpulse Orthopedics, Inc. · 2004
  • K033634Epsilon Metasul 32MM Acetabular Inserts, Standard and HoodedCenterpulse Orthopedics, Inc. · 20042 recalls
  • K040947Durasul BipolarCenterpulse Orthopedics, Inc. · 2004
  • K033810Natural-Knee II Unicompartmental Knee SystemCenterpulse Orthopedics, Inc. · 20041 recall
  • K032348Converge Reti-Lock Multi-Hole Reinforcement CupCenterpulse Orthopedics, Inc. · 2003

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/K033664 · printed Nov 5, 2026

Cite this page

510(k) Report. “K033664: Modification to Alloclassic Zweymuller SL Offset Femoral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033664

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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