510(k) Report

510(k) · Cleared

Cleared

Zenith Pedicle System

K102636510(k) TraditionalCleared Mar 3, 2011171-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

Apollo Spine, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Mar 3, 2011 as substantially equivalent to K013823 (Howmedica Osteonics Corp., 2001) after a 171-day review. Its family tree reaches back 1 generation to 2001.

Decided
Mar 3, 2011
Review
171 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K013823 (2001). No later device cites it as a predicate yet.

K013823 · Xia Spinal System · Howmedica Osteonics Corp. · 20012000200220042006200820102012
K013823 · Xia Spinal System · Howmedica Osteonics Corp. · 20010
  1. Root · 1 generation backK013823 Xia Spinal SystemHowmedica Osteonics Corp. · 2001
  2. This deviceK102636 Zenith Pedicle SystemApollo Spine, Inc. · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K013823Xia Spinal SystemHowmedica Osteonics Corp.2001—
0 (this device)K102636Zenith Pedicle SystemApollo Spine, Inc.2011—
FIG. 1 — Lineage of K102636, 2001–2011Source: 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), the FDA summary (predicates and indications), 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? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K013823Xia Spinal System
Summary page 1
…e(s): MNH, MNI Regulation Number(s): 888.3070 Noncervical. Pedicle System Predicate Device (s): * Stryker Xia Pedicle Screw Spinal System, K013823 * Amedica Valeo Pedicle Screw System, K07343 Substantial Equivalence: The Zenith Pedicle Screw System was shown to be subst…
Howmedica Osteonics Corp.2001—
Kept off the family treeK07343Amedica Valeo Pedicle Screw System
Number could not be read
Summary page 1
…(s): 888.3070 Noncervical. Pedicle System Predicate Device (s): * Stryker Xia Pedicle Screw Spinal System, K013823 * Amedica Valeo Pedicle Screw System, K07343 Substantial Equivalence: The Zenith Pedicle Screw System was shown to be substantially equivalent to previously cleared device…

Also cleared against K013823: 17 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • Its one ancestor has no recall.
  • 17 other devices also cite its predicate K013823.

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. 2011, this device’s year, is highlighted.

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—

What is it indicated for?

The Zenith Pedicle System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute arid chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, trauma (i.e., fracture or dislocation), deformities or curvatures ( i.e., scoliosis, kyphosis.…

Read the full statement (127 words)

The Zenith Pedicle System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute arid chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, trauma (i.e., fracture or dislocation), deformities or curvatures ( i.e., scoliosis, kyphosis. and/or lordosis), spinal tumor, and failed previous fusion (pseudarthrosis).

In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S I vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3-SI) with removal of implants after the attainment of a solid fusion.

Indications for use as stated in the FDA summary.

Also cleared against K013823

17 other devices cite the same predicate.

  • K213470PERLA® TL Posterior Osteosynthesis SystemSpineart · 2022
  • K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation Systems, and Trio…Stryker Spine · 2013
  • K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine · 2010
  • K092631Mantis Redux Spinal SystemStryker Spine · 2009
  • K083393Xia 3 Spinal SystemStryker Spine · 20091 recall
  • K081165Ellipse Lumbar Posterior Osteosynthesis SystemSpineart · 2008

More from Apollo Spine, Inc.

6 FDA decisions under this applicant name. See the company

  • K120340Venus Facet Screw SystemApollo Spine, Inc. · 2012
  • K102121Eclipse Vertebral Spacer System-LumbarApollo Spine, Inc. · 2011
  • K101588Eclipse Vertebral Spacer System-CervicalApollo Spine, Inc. · 2011
  • K090751Comet Anterior Cervical Plate SystemApollo Spine, Inc. · 2009
  • K082504Apollo Anterior Cervical Plate SystemApollo Spine, Inc. · 2009

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/K102636 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102636: Zenith Pedicle System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102636

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026