510(k) Report

510(k) · Cleared

Cleared

Precision Ostelock SP Femoral Component

K941141510(k) TraditionalCleared Sep 28, 1994202-day reviewClass II21 CFR 888.3358

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

Howmedica Corp. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Sep 28, 1994 after a 202-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 261 later devices descend from it.

Decided
Sep 28, 1994
Review
202 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 2 descendants cleared2000: 4 descendants cleared2007: 2 descendants cleared2002: 2 descendants cleared2011: 8 descendants cleared1998: 3 descendants cleared2001: 1 descendant cleared2021: 13 descendants cleared2020: 15 descendants cleared2012: 10 descendants cleared2009: 4 descendants cleared2017: 19 descendants cleared2014: 11 descendants cleared2013: 10 descendants cleared2015: 12 descendants cleared2016: 15 descendants cleared2018: 13 descendants cleared2006: 4 descendants cleared2005: 2 descendants cleared2008: 6 descendants cleared2004: 1 descendant cleared2025: 23 descendants cleared2003: 1 descendant cleared2010: 5 descendants cleared2019: 19 descendants cleared2026: 13 descendants cleared2023: 14 descendants cleared2024: 14 descendants cleared2022: 15 descendants cleared1990200020102020
  1. This deviceK941141 Precision Ostelock SP Femoral ComponentHowmedica Corp. · 1994
  2. Descendant · cites it directly · 255 of its ownK972228 Meridian Titanium Femoral StemsHowmedica, Inc. · 1997
  3. Descendant · 2 generations on · 224 of its ownK993768 Citation TMZF HA StemHowmedica Osteonics Corp. · 2000 · Recalled
  4. Descendant · cites it directly · 153 of its ownK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
  5. Descendant · 3 generations on · 150 of its ownK001448 Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp. · 2000
  6. Descendant · 2 generations on · 102 of its ownK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled

Showing 5 of 261 descendants. See all descendants

Descendants cleared per year

1997: 21998: 32000: 42001: 12002: 22003: 12004: 12005: 22006: 42007: 22008: 62009: 42010: 52011: 82012: 102013: 102014: 112015: 122016: 152017: 192018: 132019: 192020: 152021: 132022: 152023: 142024: 142025: 232026: 13
1997high 23 (2025) · low 0 (1999)2026

Most influential descendants

Showing 5 of 261 · See all
  • K972228Meridian Titanium Femoral StemsHowmedica, Inc. · 1997 · cites it directly255descendants
  • K993768Citation TMZF HA StemHowmedica Osteonics Corp. · 2000 · 2 generations on224descendants
  • K972893Partnership Revision Femoral StemsHowmedica Corp. · 1997 · cites it directly153descendants
  • K001448Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp. · 2000 · 3 generations on150descendants
  • K983404Type 3 Femoral ComponentsHowmedica Corp. · 1998 · 2 generations on102descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K941141Precision Ostelock SP Femoral ComponentHowmedica Corp.1994—
+1K972228Meridian Titanium Femoral StemsHowmedica, Inc.1997—
+2K993768Citation TMZF HA StemHowmedica Osteonics Corp.200012
+1K972893Partnership Revision Femoral StemsHowmedica Corp.1997—
+3K001448Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp.2000—
+2K983404Type 3 Femoral ComponentsHowmedica Corp.19981

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199830
200040
200110
200220
200310
200410
200520
200640
200720
200860
200940
201050
201180
2012100
2013100
2014110
2015120
2016150
2017190
2018130
2019190
2020150
2021130
2022150
2023140
2024140
2025230
2026130
FIG. 1 — Lineage of K941141, 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 LPH? 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 LPH device

  1. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 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? (261)

See all 261

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

NumberDeviceApplicantDecidedDescendants
K972228Meridian Titanium Femoral StemsHowmedica, Inc.1997255
K972893Partnership Revision Femoral StemsHowmedica Corp.1997153

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, K972228 (Howmedica, Inc., 1997) has gone furthest, with 255 descendants of its own.

How does its category compare?

All LPH devices

LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LPH

12in 2025

2007: 102008: 102009: 32010: 152011: 162012: 252013: 112014: 202015: 182016: 102017: 122018: 92019: 222020: 72021: 82022: 142023: 102024: 62025: 122026 (partial year): 8
2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007: 116 days median2008: 86 days median2009: 112 days median2010: 100 days median2011: 110 days median2012: 76 days median2013: 135 days median2014: 129 days median2015: 111 days median2016: 150 days median2017: 121 days median2018: 145 days median2019: 164 days median2020: 164 days median2021: 410 days median2022: 247 days median2023: 111 days median2024: 92 days median2025: 153 days median2026 (partial year): 256 days median
2007high 410 (2021) · low 76 (2012)2026

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

Recalls per year · LPH

4in 2025

2007: 162008: 12009: 22010: 222011: 262012: 302013: 92014: 32015: 12016: 82017: 142018: 22019: 82020: 62021: 42022: 22023: 22024: 12025: 42026 (partial year): 2
2007high 30 (2012) · low 1 (2008)2026

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

Adverse event reports per year · LPH

6,163in 2025

2007: 5092008: 7062009: 1,1562010: 2,0072011: 3,3202012: 3,7852013: 5,0022014: 5,1632015: 5,8302016: 4,9002017: 5,3122018: 5,9542019: 7,1302020: 5,4292021: 5,9782022: 5,2232023: 5,3452024: 5,6262025: 6,163
2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, 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
20071011616509
200810861706
2009311221,156
201015100222,007
201116110263,320
20122576303,785
20131113595,002
20142012935,163
20151811115,830
20161015084,900
201712121145,312
2018914525,954
20192216487,130
2020716465,429
2021841045,978
20221424725,223
20231011125,345
202469215,626
20251215346,163
202682562—

More from Howmedica Corp.

393 FDA decisions under this applicant name. See the company

  • N17004/S013Surgical Simplex P Bone CementHowmedica Corp. · 2000
  • N17004/S012Surgical Simplex P Radiopaque Bone CementHowmedica Corp. · 2000
  • K983528Micro Dynamic MeshHowmedica Corp. · 1998
  • K983404Type 3 Femoral ComponentsHowmedica Corp. · 19981 recall
  • K980925Duration II Tibial Inserts-Ethylene Oxide SterilizationHowmedica Corp. · 1998

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https://510kreport.com/device/K941141 · printed Nov 6, 2026

Cite this page

510(k) Report. “K941141: Precision Ostelock SP Femoral Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941141

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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