510(k) Report

510(k) · Cleared

Cleared

Osteomed M3 System (SBF System)

K924138510(k) TraditionalCleared Feb 17, 1993183-day reviewClass II21 CFR 872.4760

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

Osteomed Corp. · JEY Plate, Bone

Cleared on Feb 17, 1993 after a 183-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 582 devices in its family, counting itself, has a Class I recall. 581 later devices descend from it.

Decided
Feb 17, 1993
Review
183 days
Class
Class II
Product code
JEY
Recalls
None
Predicates
0

581 later devices descend from it, 7 citing it directly. 1 of the 582 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2011: 11 descendants cleared1996: 2 descendants cleared2009: 3 descendants cleared2003: 1 descendant cleared2001: 1 descendant cleared2008: 1 descendant cleared2017: 44 descendants cleared2005: 1 descendant cleared2021: 45 descendants cleared, 1 with a Class I recall12026: 72 descendants cleared2015: 37 descendants cleared2010: 4 descendants cleared2012: 17 descendants cleared2019: 30 descendants cleared2020: 37 descendants cleared2014: 26 descendants cleared2007: 2 descendants cleared2006: 1 descendant cleared2016: 17 descendants cleared2013: 12 descendants cleared2022: 38 descendants cleared2018: 23 descendants cleared2023: 44 descendants cleared2025: 54 descendants cleared2024: 58 descendants cleared1990200020102020
  1. This deviceK924138 Osteomed M3 System (SBF System)Osteomed Corp. · 1993
  2. Descendant · cites it directly · 548 of its ownK962236 Scarf Thread-Head ScrewLandos, Inc. · 1996
  3. Descendant · 2 generations on · 527 of its ownK062352 FRS ScrewDePuy Orthopaedics, Inc. · 2006
  4. Descendant · 3 generations on · 487 of its ownK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  5. Descendant · 4 generations on · 228 of its ownK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
  6. Descendant · 4 generations on · 161 of its ownK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011

Showing 5 of 581 descendants. See all descendants

Descendants cleared per year

1996: 22001: 12003: 12005: 12006: 12007: 22008: 12009: 32010: 42011: 112012: 172013: 122014: 262015: 372016: 172017: 442018: 232019: 302020: 372021: 452022: 382023: 442024: 582025: 542026: 72
1996high 72 (2026) · low 0 (1997)2026

Class I recalls in this family

  • K211616 ExcelsiusHub7 generations on · 2021

Most influential descendants

Showing 5 of 581 · See all
  • K962236Scarf Thread-Head ScrewLandos, Inc. · 1996 · cites it directly548descendants
  • K062352FRS ScrewDePuy Orthopaedics, Inc. · 2006 · 2 generations on527descendants
  • K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009 · 3 generations on487descendants
  • K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010 · 4 generations on228descendants
  • K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011 · 4 generations on161descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K924138Osteomed M3 System (SBF System)Osteomed Corp.1993—
+1K962236Scarf Thread-Head ScrewLandos, Inc.1996—
+2K062352FRS ScrewDePuy Orthopaedics, Inc.2006—
+3K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009—
+4K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010—
+4K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
200110
200310
200510
200610
200720
200810
200930
201040
2011110
2012170
2013120
2014260
2015370
2016170
2017440
2018230
2019300
2020370
2021451
2022380
2023440
2024580
2025540
2026720
FIG. 1 — Lineage of K924138, 1993–2026Source: 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.

1 device in this family has a Class I recall. 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 JEY device

  1. #1 K252246 Leforte MMF Systemscore 15.6 · 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (581)

See all 581

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

NumberDeviceApplicantDecidedDescendants
K962236Scarf Thread-Head ScrewLandos, Inc.1996548
K962233Twist-Off ScrewLandos, Inc.199692
K090522Osteomed Hand Plate and Screw Fixation SystemOsteomed LP200915
K031659Universal Neuro SystemStryker Instruments200312
K011946The Spin Snap-Off ScrewNew Deal, S.A.20016
K080694Osteomed Modular Locking Fixation SystemOsteomed LP20082
K111176Osteomed Low Profile Neuro Fixation SystemOsteomed LP20111

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K962236 (Landos, Inc., 1996) has gone furthest, with 548 descendants of its own.

How does its category compare?

All JEY devices

JEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JEY

2in 2025

2007: 92008: 72009: 42010: 62011: 52012: 102013: 82014: 62015: 72016: 12017: 52018: 72019: 62020: 62021: 42022: 52023: 22024: 52025: 22026 (partial year): 3
2007high 10 (2012) · low 1 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JEY

159in 2024

2007: 115 days median2008: 84 days median2009: 121 days median2010: 199 days median2011: 75 days median2012: 194 days median2013: 126 days median2014: 223 days median2015: 160 days median2017: 190 days median2018: 255 days median2019: 163 days median2020: 198 days median2021: 299 days median2022: 135 days median2024: 159 days median2026 (partial year): 258 days median
2007high 299 (2021) · low 75 (2011)2026

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

Recalls per year · JEY

1in 2020

2008: 32009: 62010: 852013: 12020: 1
2007high 85 (2010) · low 0 (2007)2026

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

Adverse event reports per year · JEY

1,003in 2025

2007: 292008: 242009: 932010: 2152011: 2412012: 4282013: 7662014: 6162015: 7672016: 5582017: 5682018: 6082019: 5952020: 6802021: 4512022: 3442023: 4952024: 6962025: 1,003
2007high 1,003 (2025) · low 24 (2008)2025

MAUDE reports naming product code JEY, 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
20079115029
2008784324
20094121693
2010619985215
20115750241
2012101940428
201381261766
201462230616
201571600767
20161—0558
201751900568
201872550608
201961630595
202061981680
202142990451
202251350344
20232—0495
202451590696
20252—01,003
202632580—

More from Osteomed Corp.

27 FDA decisions under this applicant name. See the company

  • K151021OsteoMed Cannulated Screw SystemOsteomed Corp. · 2015
  • K022277Osteomed Cranial Flap Fixation SystemOsteomed Corp. · 2003
  • K022887Interphalangeal Flexible Stabilizing Rod SystemOsteomed Corp. · 2002
  • K022886Metatarsophalangeal Flexible Stabilizing Rod SystemOsteomed Corp. · 2002
  • K0232601.2MM Osteomed Auto-Drive Screw SystemOsteomed Corp. · 2002

Recent decisions in JEY

The JEY category page

  • K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual…KLS-Martin L.P. · 2026
  • K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd. · 2026
  • K252246Leforte MMF SystemJeil Medical Corporation · 2026
  • K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd. · 2025
  • K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OY · 2025

https://510kreport.com/device/K924138 · printed Nov 6, 2026

Cite this page

510(k) Report. “K924138: Osteomed M3 System (SBF System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924138

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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