510(k) Report

510(k) · Cleared

Cleared

Osteonics Spinal System

K951725510(k) TraditionalCleared Sep 8, 1995147-day reviewClass II21 CFR 888.3070

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

Osteonics Corp. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Sep 8, 1995 after a 147-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 264 later devices descend from it.

Decided
Sep 8, 1995
Review
147 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
0

264 later devices descend from it, 16 citing it directly.

Descendants, by year cleared 2006: 3 descendants cleared2005: 3 descendants cleared2008: 2 descendants cleared1998: 2 descendants cleared2010: 3 descendants cleared1999: 3 descendants cleared2009: 5 descendants cleared2001: 1 descendant cleared2002: 2 descendants cleared2007: 5 descendants cleared2011: 7 descendants cleared2013: 5 descendants cleared2012: 11 descendants cleared2014: 10 descendants cleared2016: 10 descendants cleared2003: 1 descendant cleared2022: 16 descendants cleared2015: 12 descendants cleared2019: 13 descendants cleared2020: 18 descendants cleared2017: 12 descendants cleared2018: 17 descendants cleared2023: 28 descendants cleared2021: 7 descendants cleared2024: 25 descendants cleared2026: 23 descendants cleared2025: 20 descendants cleared1995200020052010201520202025
  1. This deviceK951725 Osteonics Spinal SystemOsteonics Corp. · 1995
  2. Descendant · cites it directly · 205 of its ownK013688 Modification to Xia Spinal SystemHowmedica Osteonics Corp. · 2001
  3. Descendant · cites it directly · 204 of its ownK063428 Xia Stainless Steel Spinal SystemStryker Spine · 2006
  4. Descendant · 2 generations on · 202 of its ownK052181 Modification to Xia Spinal SystemStryker Spine · 2005
  5. Descendant · 3 generations on · 201 of its ownK070631 Device Modification to Radius Spinal SystemStryker Spine · 2007
  6. Descendant · 4 generations on · 200 of its ownK082608 Radius Spinal System, Vitallium Rod #486613601Stryker Spine · 2008

Showing 5 of 264 descendants. See all descendants

Descendants cleared per year

1998: 21999: 32001: 12002: 22003: 12005: 32006: 32007: 52008: 22009: 52010: 32011: 72012: 112013: 52014: 102015: 122016: 102017: 122018: 172019: 132020: 182021: 72022: 162023: 282024: 252025: 202026: 23
1998high 28 (2023) · low 0 (2000)2026

Most influential descendants

Showing 5 of 264 · See all
  • K013688Modification to Xia Spinal SystemHowmedica Osteonics Corp. · 2001 · cites it directly205descendants
  • K063428Xia Stainless Steel Spinal SystemStryker Spine · 2006 · cites it directly204descendants
  • K052181Modification to Xia Spinal SystemStryker Spine · 2005 · 2 generations on202descendants
  • K070631Device Modification to Radius Spinal SystemStryker Spine · 2007 · 3 generations on201descendants
  • K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine · 2008 · 4 generations on200descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951725Osteonics Spinal SystemOsteonics Corp.1995—
+1K013688Modification to Xia Spinal SystemHowmedica Osteonics Corp.2001—
+1K063428Xia Stainless Steel Spinal SystemStryker Spine2006—
+2K052181Modification to Xia Spinal SystemStryker Spine2005—
+3K070631Device Modification to Radius Spinal SystemStryker Spine2007—
+4K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
199930
200110
200220
200310
200530
200630
200750
200820
200950
201030
201170
2012110
201350
2014100
2015120
2016100
2017120
2018170
2019130
2020180
202170
2022160
2023280
2024250
2025200
2026230
FIG. 1 — Lineage of K951725, 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 MNH? 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? (264)

See all 264

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

NumberDeviceApplicantDecidedDescendants
K013688Modification to Xia Spinal SystemHowmedica Osteonics Corp.2001205
K063428Xia Stainless Steel Spinal SystemStryker Spine2006204
K061813Mantis Spinal SystemStryker Spine2006135
K052971Stryker Spine Trio Spinal Fixation SystemStryker Spine2005112
K073151Mantis Spinal SystemStryker Corp.2007111
K092631Mantis Redux Spinal SystemStryker Spine2009110
K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine2010109
K062698Trio + Spinal SystemStryker Spine200688
K043180Stryker Spine Trio PSStryker Spine200588
K072116Savannah Lumbar Percutaneous Stabilization SystemNeurospine Innovations and Solutions200824

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, K013688 (Howmedica Osteonics Corp., 2001) has gone furthest, with 205 descendants of its own.

How does its category compare?

All MNH devices

MNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNH

8in 2016

2007: 52008: 132009: 132010: 102011: 172012: 72013: 102014: 122015: 102016: 8
2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007: 123 days median2008: 65 days median2009: 151 days median2010: 106 days median2011: 171 days median2012: 93 days median2013: 124 days median2014: 140 days median2015: 99 days median2016: 93 days median
2007high 171 (2011) · low 65 (2008)2026

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

Recalls per year · MNH

1in 2016

2009: 72012: 12013: 12016: 1
2007high 7 (2009) · low 0 (2007)2026

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

Adverse event reports per year · MNH

89in 2025

2007: 182008: 302009: 452010: 592011: 1072012: 4332013: 4642014: 2862015: 1522016: 2162017: 1742018: 1292019: 4032020: 4322021: 5312022: 2652023: 1212024: 3022025: 89
2007high 531 (2021) · low 18 (2007)2025

MAUDE reports naming product code MNH, 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
20075123018
20081365030
200913151745
201010106059
2011171710107
20127931433
2013101241464
2014121400286
201510990152
20168931216
20170—0174
20180—0129
20190—0403
20200—0432
20210—0531
20220—0265
20230—0121
20240—0302
20250—089
20260—0—

More from Osteonics Corp.

178 FDA decisions under this applicant name. See the company

  • K983657Osteonics Series 7000 AD Tibial TrayOsteonics Corp. · 2000
  • K980070Osteonics HA-Coated DevicesOsteonics Corp. · 1999
  • K984375Osteonics Spinal System - Sacral Offset Connector AssemblyOsteonics Corp. · 1999
  • K982798Osteonics Anterior Cervical Compression Plating SystemOsteonics Corp. · 1999
  • K984585Osteonics +10 Unipolar Adaptor SleeveOsteonics Corp. · 1999

Recent decisions in MNH

The MNH category page

  • K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016
  • K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2016
  • K162143FixxSure® X-LinkInnovasis, Inc. · 2016
  • K161151Spinal fixation systemCanwell Medical Co., Ltd. · 2016
  • K162189ANAX™ 5.5 Spinal SystemU&I Corporation · 2016

https://510kreport.com/device/K951725 · printed Nov 4, 2026

Cite this page

510(k) Report. “K951725: Osteonics Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951725

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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