510(k) Report

510(k) · Cleared

Cleared

Xia Spine System Hooks

K001319510(k) SpecialCleared May 23, 200027-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

Howmedica Osteonics Corp. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on May 23, 2000 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 695 later devices descend from it.

Decided
May 23, 2000
Review
27 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
0

695 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2003: 4 descendants cleared2008: 17 descendants cleared2009: 14 descendants cleared2015: 38 descendants cleared2014: 36 descendants cleared2001: 1 descendant cleared2002: 1 descendant cleared2005: 6 descendants cleared2023: 60 descendants cleared2011: 14 descendants cleared2010: 15 descendants cleared2007: 11 descendants cleared2012: 28 descendants cleared2018: 45 descendants cleared2013: 29 descendants cleared2006: 6 descendants cleared2016: 37 descendants cleared2004: 1 descendant cleared2019: 31 descendants cleared2024: 53 descendants cleared2017: 40 descendants cleared2022: 43 descendants cleared2021: 31 descendants cleared2020: 41 descendants cleared2025: 49 descendants cleared2026: 44 descendants cleared200020052010201520202025
  1. This deviceK001319 Xia Spine System HooksHowmedica Osteonics Corp. · 2000
  2. Descendant · cites it directly · 579 of its ownK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
  3. Descendant · cites it directly · 466 of its ownK024096 Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
  4. Descendant · cites it directly · 205 of its ownK013688 Modification to Xia Spinal SystemHowmedica Osteonics Corp. · 2001
  5. Descendant · 2 generations on · 202 of its ownK052181 Modification to Xia Spinal SystemStryker Spine · 2005
  6. Descendant · 3 generations on · 201 of its ownK070631 Device Modification to Radius Spinal SystemStryker Spine · 2007

Showing 5 of 695 descendants. See all descendants

Descendants cleared per year

2001: 12002: 12003: 42004: 12005: 62006: 62007: 112008: 172009: 142010: 152011: 142012: 282013: 292014: 362015: 382016: 372017: 402018: 452019: 312020: 412021: 312022: 432023: 602024: 532025: 492026: 44
2001high 60 (2023) · low 1 (2001)2026

Most influential descendants

Showing 5 of 695 · See all
  • K031585U&I, Optima, Spinal SystemU&I Corp., America · 2003 · cites it directly579descendants
  • K024096Optima, Spinal SystemU&I Corp., America · 2003 · cites it directly466descendants
  • K013688Modification to Xia Spinal SystemHowmedica Osteonics Corp. · 2001 · cites it directly205descendants
  • K052181Modification to Xia Spinal SystemStryker Spine · 2005 · 2 generations on202descendants
  • K070631Device Modification to Radius Spinal SystemStryker Spine · 2007 · 3 generations on201descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001319Xia Spine System HooksHowmedica Osteonics Corp.2000—
+1K031585U&I, Optima, Spinal SystemU&I Corp., America20035
+1K024096Optima, Spinal SystemU&I Corp., America20033
+1K013688Modification to Xia Spinal SystemHowmedica Osteonics Corp.2001—
+2K052181Modification to Xia Spinal SystemStryker Spine2005—
+3K070631Device Modification to Radius Spinal SystemStryker Spine2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
200340
200410
200560
200660
2007110
2008170
2009140
2010150
2011140
2012280
2013290
2014360
2015380
2016370
2017400
2018450
2019310
2020410
2021310
2022430
2023600
2024530
2025490
2026440
FIG. 1 — Lineage of K001319, 2000–2026Source: 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? (695)

See all 695

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

NumberDeviceApplicantDecidedDescendants
K031585U&I, Optima, Spinal SystemU&I Corp., America2003579
K024096Optima, Spinal SystemU&I Corp., America2003466
K013688Modification to Xia Spinal SystemHowmedica Osteonics Corp.2001205
K072116Savannah Lumbar Percutaneous Stabilization SystemNeurospine Innovations and Solutions200824
K031595U & I America Spinal Hook SystemU&I Corp., America200314
K151849Seneka I Polyscrew Pedicle Fixation SystemSenecka Spine20151
K133066Spineselect Polyscrew Pedicle Screw SystemSpineselect, LLC20140
K083178Solas Anatomix Spinal SystemBiotechni America Spine Group, Inc.20090

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, K031585 (U&I Corp., America, 2003) has gone furthest, with 579 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 Howmedica Osteonics Corp.

319 FDA decisions under this applicant name. See the company

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  • P000013/S025Trident® Acetabular SystemHowmedica Osteonics Corp. · 2024
  • P000013/S024Trident (R), ABC (R)Howmedica Osteonics Corp. · 2024
  • P000013/S021Trident Ceramic SystemHowmedica Osteonics Corp. · 2023

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https://510kreport.com/device/K001319 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001319: Xia Spine System Hooks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001319

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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