510(k) Report

510(k) · Cleared

Cleared

Universal Multiaxis (Unimax) Pedicle Screw System

K014302510(k) TraditionalCleared Mar 29, 200288-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

Pisharodi Surgicals, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Mar 29, 2002 as substantially equivalent to K001532 (Medtronic Sofamor Danek, Inc., 2000) after an 88-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.

Decided
Mar 29, 2002
Review
88 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K001532 (2000). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant clearedK001532 · Dyna-Lok Classic Spinal System · Medtronic Sofamor Danek, Inc. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant K001532 · Dyna-Lok Classic Spinal System · Medtronic Sofamor Danek, Inc. · 20000
  1. Root · 1 generation backK001532 Dyna-Lok Classic Spinal SystemMedtronic Sofamor Danek, Inc. · 2000
  2. This deviceK014302 Universal Multiaxis (Unimax) Pedicle Screw SystemPisharodi Surgicals, Inc. · 2002
  3. Descendant · cites it directly · 0 of its ownK024313 Modification to Universal Multiaxis (Unimax) Pedicle Screw SystemPisharodi Surgicals, Inc. · 2003

Most influential descendants

Showing 1 of 1 · See all
  • K024313Modification to Universal Multiaxis (Unimax) Pedicle Screw SystemPisharodi Surgicals, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K001532Dyna-Lok Classic Spinal SystemMedtronic Sofamor Danek, Inc.2000—
0 (this device)K014302Universal Multiaxis (Unimax) Pedicle Screw SystemPisharodi Surgicals, Inc.2002—
+1K024313Modification to Universal Multiaxis (Unimax) Pedicle Screw SystemPisharodi Surgicals, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
FIG. 1 — Lineage of K014302, 2000–2003Source: 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? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K001532Dyna-Lok Classic Spinal System
Summary page 1
…rthopedic Devices Panel -Code 87, Product Code MNI) 21 CFR 888.3070 - Pedicle Screw Spinal System Predicate DYNA-LOK CLASSIC Spinal System, Medtronic Sofamor Danek USA (K001532) Device Description The UNIMAX Pedicle Screw System consists of plates, bolts, screws and washers and is used to build a spinal…
Medtronic Sofamor Danek, Inc.2000—

Also cleared against K001532: 2 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K024313Modification to Universal Multiaxis (Unimax) Pedicle Screw SystemPisharodi Surgicals, Inc.20030

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.
  • Of its descendants, K024313 (Pisharodi Surgicals, Inc., 2003) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K001532.

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—

What is it indicated for?

The Universal MultiaAXis (UNIMAX™) Pedicle Screw System is intended to provide immobilization and stabilization of non-cervical posterior spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) Degenerative spondylolisthesis with objective neurological impairment; (2) Fracture; (3) Dislocation; (4) Scoliosis; (5)…

Read the full statement (150 words)

The Universal MultiaAXis (UNIMAX™) Pedicle Screw System is intended to provide immobilization and stabilization of non-cervical posterior spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:

(1) Degenerative spondylolisthesis with objective neurological impairment; (2) Fracture; (3) Dislocation; (4) Scoliosis; (5) Kyphosis; (8) Spinal tumor, and (7) Failed previous fusion (pseudoarthrosis)."

When used as a pedicle screw fixation system the UNIMAX Pedicle Screw System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L.5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (¢} who are having the device fixed or attached to the lumbar and sacral spine (.3 and balow); and (4) who are having the device removed after the development of a solid fusion mass.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K001532

2 other devices cite the same predicate.

  • K041862CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  • K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 20044 recalls

More from Pisharodi Surgicals, Inc.

4 FDA decisions under this applicant name. See the company

  • K070335Simplex Cervical Fixation SystemPisharodi Surgicals, Inc. · 2007
  • K033951Radix Cervical PlatePisharodi Surgicals, Inc. · 2004
  • K024313Modification to Universal Multiaxis (Unimax) Pedicle Screw SystemPisharodi Surgicals, Inc. · 2003

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/K014302 · printed Nov 6, 2026

Cite this page

510(k) Report. “K014302: Universal Multiaxis (Unimax) Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014302

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026