510(k) Report

510(k) · Cleared

Cleared

SL-Plus & SLR-Plus Stems W/Biolox Ceramic Heads

K930963510(k) TraditionalCleared Jan 7, 1994317-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

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

Cleared on Jan 7, 1994 after a 317-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 286 later devices descend from it.

Decided
Jan 7, 1994
Review
317 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
0

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

Descendants, by year cleared 2005: 3 descendants cleared1996: 2 descendants cleared2008: 8 descendants cleared2014: 16 descendants cleared2017: 17 descendants cleared2003: 2 descendants cleared2019: 16 descendants cleared2006: 6 descendants cleared2010: 6 descendants cleared2020: 17 descendants cleared2025: 23 descendants cleared2015: 12 descendants cleared2011: 12 descendants cleared2018: 15 descendants cleared2013: 16 descendants cleared2007: 2 descendants cleared2009: 5 descendants cleared2016: 9 descendants cleared2021: 18 descendants cleared2022: 15 descendants cleared2012: 18 descendants cleared2026: 20 descendants cleared2023: 16 descendants cleared2024: 12 descendants cleared1990200020102020
  1. This deviceK930963 SL-Plus & SLR-Plus Stems W/Biolox Ceramic HeadsEncore Orthopedics, Inc. · 1994
  2. Descendant · cites it directly · 283 of its ownK962101 Zweymueller SL Femoral Hip StemIntermedics Orthopedics · 1996
  3. Descendant · 2 generations on · 278 of its ownK030373 Alloclassic Zweymueller SL/SLL Femoral StemCenterpulse Orthopedics, Inc. · 2003 · Recalled
  4. Descendant · 3 generations on · 198 of its ownK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
  5. Descendant · 4 generations on · 90 of its ownK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
  6. Descendant · 4 generations on · 90 of its ownK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006

Showing 5 of 286 descendants. See all descendants

Descendants cleared per year

1996: 22003: 22005: 32006: 62007: 22008: 82009: 52010: 62011: 122012: 182013: 162014: 162015: 122016: 92017: 172018: 152019: 162020: 172021: 182022: 152023: 162024: 122025: 232026: 20
1996high 23 (2025) · low 0 (1997)2026

Most influential descendants

Showing 5 of 286 · See all
  • K962101Zweymueller SL Femoral Hip StemIntermedics Orthopedics · 1996 · cites it directly283descendants
  • K030373Alloclassic Zweymueller SL/SLL Femoral StemCenterpulse Orthopedics, Inc. · 2003 · 2 generations on278descendants
  • K042344Excia Total Hip SystemAesculap, Inc. · 2005 · 3 generations on198descendants
  • K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006 · 4 generations on90descendants
  • K060437Excia Total Hip System with U-CapAesculap, Inc. · 2006 · 4 generations on90descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K930963SL-Plus & SLR-Plus Stems W/Biolox Ceramic HeadsEncore Orthopedics, Inc.1994—
+1K962101Zweymueller SL Femoral Hip StemIntermedics Orthopedics1996—
+2K030373Alloclassic Zweymueller SL/SLL Femoral StemCenterpulse Orthopedics, Inc.20031
+3K042344Excia Total Hip SystemAesculap, Inc.200510
+4K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc.2006—
+4K060437Excia Total Hip System with U-CapAesculap, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
200320
200530
200660
200720
200880
200950
201060
2011120
2012180
2013160
2014160
2015120
201690
2017170
2018150
2019160
2020170
2021180
2022150
2023160
2024120
2025230
2026200
FIG. 1 — Lineage of K930963, 1994–2026Source: 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (286)

See all 286

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

NumberDeviceApplicantDecidedDescendants
K962101Zweymueller SL Femoral Hip StemIntermedics Orthopedics1996283
K955563Foundation Forged, Textured & Porous Stems W/Biolox Ceramic HeadsEncore Orthopedics, Inc.19961
K051826Betacone Hip Prosthesis SystemWaldemar Link GmbH & Co. KG20050

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, K962101 (Intermedics Orthopedics, 1996) has gone furthest, with 283 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 Encore Orthopedics, Inc.

85 FDA decisions under this applicant name. See the company

  • K0329053DKNEE Porous Coated Femoral ComponentEncore Orthopedics, Inc. · 2004
  • K0201143D KNEEEncore Orthopedics, Inc. · 20025 recalls
  • K020741Unicondylar KneeEncore Orthopedics, Inc. · 20022 recalls
  • K020236Modification to Pass Spinal SystemEncore Orthopedics, Inc. · 2002
  • K020170Keystone Hip System Calcar Replacement Body and Build UPEncore Orthopedics, Inc. · 2002

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/K930963 · printed Nov 6, 2026

Cite this page

510(k) Report. “K930963: SL-Plus & SLR-Plus Stems W/Biolox Ceramic Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930963

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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