510(k) Report

510(k) · Cleared

Cleared

Corin Modular Moore Stem

K881288510(k) TraditionalCleared Jun 29, 198893-day reviewClass II21 CFR 888.3360

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

Orthopedic Systems, Inc. · LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

Cleared on Jun 29, 1988 after a 93-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 122 later devices descend from it.

Decided
Jun 29, 1988
Review
93 days
Class
Class II
Product code
LWJ
Recalls
None
Predicates
0

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

Descendants, by year cleared 1996: 1 descendant cleared1999: 1 descendant cleared2001: 1 descendant cleared2002: 1 descendant cleared2004: 1 descendant cleared2005: 1 descendant cleared2012: 4 descendants cleared2006: 4 descendants cleared2008: 2 descendants cleared2013: 5 descendants cleared2011: 2 descendants cleared2009: 1 descendant cleared2015: 6 descendants cleared2016: 7 descendants cleared2021: 8 descendants cleared2017: 6 descendants cleared2018: 8 descendants cleared2019: 14 descendants cleared2020: 12 descendants cleared2025: 7 descendants cleared2026: 9 descendants cleared2024: 8 descendants cleared2014: 5 descendants cleared2022: 3 descendants cleared2023: 5 descendants cleared1990200020102020
  1. This deviceK881288 Corin Modular Moore StemOrthopedic Systems, Inc. · 1988
  2. Descendant · cites it directly · 121 of its ownK960538 Opteon UnipolarExactech, Inc. · 1996
  3. Descendant · 2 generations on · 117 of its ownK984028 The New Bio-Moore Endo HeadsBiomet, Inc. · 1999
  4. Descendant · 3 generations on · 116 of its ownK042037 M2A Magnum SystemBiomet, Inc. · 2004
  5. Descendant · 4 generations on · 74 of its ownK053536 Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH · 2006 · Recalled
  6. Descendant · 5 generations on · 73 of its ownK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled

Showing 5 of 122 descendants. See all descendants

Descendants cleared per year

1996: 11999: 12001: 12002: 12004: 12005: 12006: 42008: 22009: 12011: 22012: 42013: 52014: 52015: 62016: 72017: 62018: 82019: 142020: 122021: 82022: 32023: 52024: 82025: 72026: 9
1996high 14 (2019) · low 0 (1997)2026

Most influential descendants

Showing 5 of 122 · See all
  • K960538Opteon UnipolarExactech, Inc. · 1996 · cites it directly121descendants
  • K984028The New Bio-Moore Endo HeadsBiomet, Inc. · 1999 · 2 generations on117descendants
  • K042037M2A Magnum SystemBiomet, Inc. · 2004 · 3 generations on116descendants
  • K053536Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH · 2006 · 4 generations on74descendants
  • K071723Zimmer Porolock Mis StemZimmer GmbH · 2008 · 5 generations on73descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K881288Corin Modular Moore StemOrthopedic Systems, Inc.1988—
+1K960538Opteon UnipolarExactech, Inc.1996—
+2K984028The New Bio-Moore Endo HeadsBiomet, Inc.1999—
+3K042037M2A Magnum SystemBiomet, Inc.2004—
+4K053536Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH200613
+5K071723Zimmer Porolock Mis StemZimmer GmbH20082

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199910
200110
200210
200410
200510
200640
200820
200910
201120
201240
201350
201450
201560
201670
201760
201880
2019140
2020120
202180
202230
202350
202480
202570
202690
FIG. 1 — Lineage of K881288, 1988–2026Source: 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 LWJ? 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? (122)

See all 122

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

NumberDeviceApplicantDecidedDescendants
K960538Opteon UnipolarExactech, Inc.1996121

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, K960538 (Exactech, Inc., 1996) has gone furthest, with 121 descendants of its own.

How does its category compare?

All LWJ devices

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

FDA decisions per year · LWJ

1in 2012

2007: 22008: 12009: 12011: 12012: 1
2007high 2 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LWJ

Too few LWJ 510(k)s in any year since 2007 to give a median.

Recalls per year · LWJ

2in 2023

2007: 102008: 22009: 22013: 12023: 2
2007high 10 (2007) · low 0 (2010)2026

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

Adverse event reports per year · LWJ

51in 2025

2007: 682008: 722009: 842010: 1322011: 2552012: 3902013: 5222014: 4522015: 3102016: 2932017: 3112018: 2272019: 2102020: 1892021: 1552022: 912023: 722024: 542025: 51
2007high 522 (2013) · low 51 (2025)2025

MAUDE reports naming product code LWJ, 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—1068
20081—272
20091—284
20100—0132
20111—0255
20121—0390
20130—1522
20140—0452
20150—0310
20160—0293
20170—0311
20180—0227
20190—0210
20200—0189
20210—0155
20220—091
20230—272
20240—054
20250—051
20260—0—

More from Orthopedic Systems, Inc.

95 FDA decisions under this applicant name. See the company

  • K952495Anchors Away Soft Tissue Attachment SystemOrthopedic Systems, Inc. · 1996
  • K920256Spine Motion Analyzer with EmgOrthopedic Systems, Inc. · 1992
  • K910736Jackson Multipurpose Operating TableOrthopedic Systems, Inc. · 19911 recall
  • K910031Park City Shoulder PositionerOrthopedic Systems, Inc. · 1991
  • K903938C Fit CupOrthopedic Systems, Inc. · 1991

Recent decisions in LWJ

The LWJ category page

  • K120595Unisyn Plus Hip StemConsensus Orthopedics, Inc. · 2012
  • K103518Trinity Acetabular SystemCorin USA · 2011
  • K090764Novation CFS Press-Fit and Cemented StemsExactech, Inc. · 2009
  • K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc. · 2008
  • K07006136MM Cocr Femoral Head and 36MM Acetabular InsertHayes Medical, Inc. · 2007

https://510kreport.com/device/K881288 · printed Nov 6, 2026

Cite this page

510(k) Report. “K881288: Corin Modular Moore Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K881288

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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