510(k) Report

510(k) · Cleared

Recalled · 2011

Osteonics Restoration Monolithic II Slotted Hip Stem Series

K951671510(k) TraditionalCleared Sep 6, 1995148-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

Osteonics Corp. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Cleared on Sep 6, 1995 after a 148-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 154 later devices descend from it. It has been recalled once.

Decided
Sep 6, 1995
Review
148 days
Class
Class II
Product code
MEH
Recalls
1
Predicates
0

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

Descendants, by year cleared 1997: 1 descendant cleared2002: 2 descendants cleared2000: 1 descendant cleared1998: 3 descendants cleared2001: 1 descendant cleared2021: 9 descendants cleared2020: 10 descendants cleared2012: 6 descendants cleared2009: 1 descendant cleared2011: 2 descendants cleared2008: 1 descendant cleared2016: 11 descendants cleared2015: 8 descendants cleared2004: 1 descendant cleared2006: 1 descendant cleared2025: 14 descendants cleared2003: 1 descendant cleared2010: 2 descendants cleared2013: 5 descendants cleared2017: 13 descendants cleared2018: 6 descendants cleared2019: 14 descendants cleared2014: 4 descendants cleared2022: 11 descendants cleared2007: 1 descendant cleared2023: 7 descendants cleared2024: 9 descendants cleared2026: 9 descendants cleared1995200020052010201520202025
  1. This deviceK951671 Osteonics Restoration Monolithic II Slotted Hip Stem SeriesOsteonics Corp. · 1995
  2. Descendant · cites it directly · 153 of its ownK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
  3. Descendant · 2 generations on · 102 of its ownK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
  4. Descendant · 2 generations on · 101 of its ownK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
  5. Descendant · 2 generations on · 69 of its ownK001449 Trident Acetabular Shells: PSHowmedica Osteonics Corp. · 2000
  6. Descendant · 3 generations on · 68 of its ownK013676 Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp. · 2001 · Recalled

Showing 5 of 154 descendants. See all descendants

Descendants cleared per year

1997: 11998: 32000: 12001: 12002: 22003: 12004: 12006: 12007: 12008: 12009: 12010: 22011: 22012: 62013: 52014: 42015: 82016: 112017: 132018: 62019: 142020: 102021: 92022: 112023: 72024: 92025: 142026: 9
1997high 14 (2019) · low 0 (1999)2026

Most influential descendants

Showing 5 of 154 · See all
  • K972893Partnership Revision Femoral StemsHowmedica Corp. · 1997 · cites it directly153descendants
  • K983404Type 3 Femoral ComponentsHowmedica Corp. · 1998 · 2 generations on102descendants
  • K0131062 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · 2 generations on101descendants
  • K001449Trident Acetabular Shells: PSHowmedica Osteonics Corp. · 2000 · 2 generations on69descendants
  • K013676Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp. · 2001 · 3 generations on68descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951671Osteonics Restoration Monolithic II Slotted Hip Stem SeriesOsteonics Corp.1995—
+1K972893Partnership Revision Femoral StemsHowmedica Corp.1997—
+2K983404Type 3 Femoral ComponentsHowmedica Corp.19981
+2K0131062 Piece Modular Hip StemHowmedica Osteonics Corp.200237
+2K001449Trident Acetabular Shells: PSHowmedica Osteonics Corp.2000—
+3K013676Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp.20018

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199830
200010
200110
200220
200310
200410
200610
200710
200810
200910
201020
201120
201260
201350
201440
201580
2016110
2017130
201860
2019140
2020100
202190
2022110
202370
202490
2025140
202690
FIG. 1 — Lineage of K951671, 1995–2026Source: 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 MEH? 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 MEH device

  1. #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (154)

See all 154

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

NumberDeviceApplicantDecidedDescendants
K972893Partnership Revision Femoral StemsHowmedica Corp.1997153

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

Recalls of this device

DateClassRecallRoot causeReason
Oct 27, 2011Not classifiedZ-1677-2012Error in labelingAn incorrect laser mark was noted on specific lots of product, incorrectly implying a stem size of 9, when the product is actually size 8.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K972893 (Howmedica Corp., 1997) has gone furthest, with 153 descendants of its own.

How does its category compare?

All MEH devices

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

FDA decisions per year · MEH

5in 2025

2007: 22008: 62009: 62010: 52011: 52012: 62013: 12015: 22016: 62017: 32018: 22019: 12020: 32021: 32022: 32023: 22024: 62025: 52026 (partial year): 1
2007high 6 (2008) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MEH

87in 2025

2008: 79 days median2009: 65 days median2010: 226 days median2011: 95 days median2012: 131 days median2016: 163 days median2017: 209 days median2020: 131 days median2021: 83 days median2022: 150 days median2024: 91 days median2025: 87 days median
2007high 226 (2010) · low 65 (2009)2026

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

Recalls per year · MEH

1in 2025

2007: 32008: 802009: 512010: 162011: 42012: 32014: 12015: 12016: 42017: 12018: 32020: 12025: 12026 (partial year): 1
2007high 80 (2008) · low 0 (2013)2026

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

Adverse event reports per year · MEH

470in 2025

2007: 252008: 2612009: 5392010: 4622011: 4192012: 1,6062013: 1,2952014: 1,1962015: 4902016: 3472017: 3832018: 3372019: 3352020: 3382021: 3722022: 3162023: 3342024: 3542025: 470
2007high 1,606 (2012) · low 25 (2007)2025

MAUDE reports naming product code MEH, 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
20072—325
200867980261
200966551539
2010522616462
20115954419
2012613131,606
20131—01,295
20140—11,196
20152—1490
201661634347
201732091383
20182—3337
20191—0335
202031311338
20213830372
202231500316
20232—0334
20246910354
20255871470
20261—1—

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Recent decisions in MEH

The MEH category page

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https://510kreport.com/device/K951671 · printed Nov 6, 2026

Cite this page

510(k) Report. “K951671: Osteonics Restoration Monolithic II Slotted Hip Stem Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951671

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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