510(k) Report

510(k) · Cleared

Cleared

Zweymueller-SL Hip Prosthesis Stem

K871453510(k) TraditionalCleared Jul 13, 198791-day reviewClass III21 CFR 888.3330

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

Allo Pro Corp. · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

Cleared on Jul 13, 1987 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 284 later devices descend from it.

Decided
Jul 13, 1987
Review
91 days
Class
Class III
Product code
KWA
Recalls
None
Predicates
0

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

Descendants, by year cleared 1996: 1 descendant cleared2014: 16 descendants cleared2017: 17 descendants cleared2003: 2 descendants cleared2019: 16 descendants cleared2005: 3 descendants cleared2008: 7 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 deviceK871453 Zweymueller-SL Hip Prosthesis StemAllo Pro Corp. · 1987
  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 284 descendants. See all descendants

Descendants cleared per year

1996: 12003: 22005: 32006: 62007: 22008: 72009: 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 284 · 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)K871453Zweymueller-SL Hip Prosthesis StemAllo Pro Corp.1987—
+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
199610
200320
200530
200660
200720
200870
200950
201060
2011120
2012180
2013160
2014160
2015120
201690
2017170
2018150
2019160
2020170
2021180
2022150
2023160
2024120
2025230
2026200
FIG. 1 — Lineage of K871453, 1987–2026Source: 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 KWA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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? (284)

See all 284

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

NumberDeviceApplicantDecidedDescendants
K962101Zweymueller SL Femoral Hip StemIntermedics Orthopedics1996283

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 KWA devices

KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWA

4in 2012

2007: 82008: 92009: 72010: 62011: 112012: 4
2007high 11 (2011) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWA

76in 2012

2007: 74 days median2008: 57 days median2009: 139 days median2010: 167 days median2011: 101 days median2012: 76 days median
2007high 167 (2010) · low 57 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWA

19in 2023

2008: 132010: 842011: 282012: 212013: 12016: 12017: 12018: 12019: 22020: 12023: 19
2007high 84 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWA

1,216in 2025

2007: 2132008: 7622009: 8202010: 3,3482011: 17,7372012: 24,6012013: 20,0202014: 16,4942015: 12,3392016: 7,8722017: 6,8472018: 6,3882019: 7,6282020: 4,5382021: 2,0642022: 1,6172023: 1,4742024: 1,1682025: 1,216
2007high 24,601 (2012) · low 213 (2007)2025

MAUDE reports naming product code KWA, 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
20078740213
200895713762
200971390820
20106167843,348
2011111012817,737
20124762124,601
20130—120,020
20140—016,494
20150—012,339
20160—17,872
20170—16,847
20180—16,388
20190—27,628
20200—14,538
20210—02,064
20220—01,617
20230—191,474
20240—01,168
20250—01,216
20260—0—

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https://510kreport.com/device/K871453 · printed Nov 5, 2026

Cite this page

510(k) Report. “K871453: Zweymueller-SL Hip Prosthesis Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K871453

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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