510(k) Report

510(k) · Cleared

Cleared

Omc Orthomet Cannulated Screw

K862157510(k) TraditionalCleared Aug 29, 198685-day review

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

Orthomet, Inc.

Cleared on Aug 29, 1986 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.

Decided
Aug 29, 1986
Review
85 days
Recalls
None
Predicates
0

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

Descendants, by year cleared 2005: 1 descendant cleared2008: 1 descendant cleared2011: 2 descendants cleared2014: 1 descendant cleared2017: 1 descendant cleared2026: 1 descendant cleared2025: 2 descendants cleared2019: 1 descendant cleared2016: 1 descendant cleared2020: 2 descendants cleared1990200020102020
  1. This deviceK862157 Omc Orthomet Cannulated ScrewOrthomet, Inc. · 1986
  2. Descendant · cites it directly · 12 of its ownK043410 Epiphysis ScrewI.T.S. Implantat-Technologie-Systeme GmbH · 2005
  3. Descendant · 2 generations on · 11 of its ownK082949 Orthopediatrics Bone ScrewsOrthoPediatrics Corp. · 2008
  4. Descendant · 3 generations on · 7 of its ownK111086 Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp. · 2011 · Recalled
  5. Descendant · 4 generations on · 2 of its ownK192181 PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · Recalled
  6. Descendant · 3 generations on · 2 of its ownK110959 Orthopediatrics Blade Plate SystemOrthoPediatrics Corp. · 2011 · Recalled

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2005: 12008: 12011: 22014: 12016: 12017: 12019: 12020: 22025: 22026: 1
2005high 2 (2011) · low 0 (2006)2026

Most influential descendants

Showing 5 of 13 · See all
  • K043410Epiphysis ScrewI.T.S. Implantat-Technologie-Systeme GmbH · 2005 · cites it directly12descendants
  • K082949Orthopediatrics Bone ScrewsOrthoPediatrics Corp. · 2008 · 2 generations on11descendants
  • K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp. · 2011 · 3 generations on7descendants
  • K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · 4 generations on2descendants
  • K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp. · 2011 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K862157Omc Orthomet Cannulated ScrewOrthomet, Inc.1986—
+1K043410Epiphysis ScrewI.T.S. Implantat-Technologie-Systeme GmbH2005—
+2K082949Orthopediatrics Bone ScrewsOrthoPediatrics Corp.2008—
+3K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.20111
+4K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.20191
+3K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.20113

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200810
201120
201410
201610
201710
201910
202020
202520
202610
FIG. 1 — Lineage of K862157, 1986–2026Source: 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.

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  • 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? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K043410Epiphysis ScrewI.T.S. Implantat-Technologie-Systeme GmbH200512

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, K043410 (I.T.S. Implantat-Technologie-Systeme GmbH, 2005) has gone furthest, with 12 descendants of its own.

More from Orthomet, Inc.

60 FDA decisions under this applicant name. See the company

  • K936310Orthomet HMC Femoral Stem ComponentOrthomet, Inc. · 1995
  • K945783Orthomet Titanium Hybrid Femoral StemOrthomet, Inc. · 1995
  • K943873Orthomet Anatomically Guided Carpal Tunnel Release SYOrthomet, Inc. · 1995
  • K944752Orthomet Resurfacing Femoral ComponentOrthomet, Inc. · 1994
  • K930771Perfecta Total Hip System Coated Cocr Femoral StemOrthomet, Inc. · 1994

https://510kreport.com/device/K862157 · printed Nov 6, 2026

Cite this page

510(k) Report. “K862157: Omc Orthomet Cannulated Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K862157

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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