510(k) Report

510(k) · Cleared

Cleared

Amt Polyaxial Pedicle Screw

K022768510(k) TraditionalCleared Nov 13, 200284-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

Micron Precision Engineering, Inc. · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Nov 13, 2002 as substantially equivalent to K002059 (Micron Precision Engineering, Inc., 2000) after an 84-day review. Its family tree reaches back 1 generation to 2000.

Decided
Nov 13, 2002
Review
84 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K002059 (2000). No later device cites it as a predicate yet.

K002059 · Amt Spinal System · Micron Precision Engineering, Inc. · 2000200020022004
K002059 · Amt Spinal System · Micron Precision Engineering, Inc. · 20000
  1. Root · 1 generation backK002059 Amt Spinal SystemMicron Precision Engineering, Inc. · 2000
  2. This deviceK022768 Amt Polyaxial Pedicle ScrewMicron Precision Engineering, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002059Amt Spinal SystemMicron Precision Engineering, Inc.2000—
0 (this device)K022768Amt Polyaxial Pedicle ScrewMicron Precision Engineering, Inc.2002—
FIG. 1 — Lineage of K022768, 2000–2002Source: 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 MNI? 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? (6)

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
*K002059Amt Spinal System
Summary page 2
…. The AMT Polyaxial Pedicle Screw serves as an additional option to the pedicle screw configurations currently offered in the AMT SpinalTMSystem (K002059), in a construct system. The AMT Polyaxial Pedicle Screw utilizes the same straight forward simple instruments and is…
Micron Precision Engineering, Inc.2000—
*—Spine System Evolution - Aesculap
Named without a submission number
—
*—Global Spinal Fixation System - Forex
Named without a submission number
—
*—Global Spinal Fixation System - U & I Corporation
Named without a submission number
—
*—Spiral Radius 90D - Surgical Dynamics
Named without a submission number
—
*—Trinity Polyaxial Screw - Corin Spinal Systems
Named without a submission number
—

Also cleared against K002059: 4 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.
  • 4 other devices also cite its predicate K002059.

How does its category compare?

All MNI devices

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

FDA decisions per year · MNI

1in 2017

2007: 202008: 232009: 182010: 162011: 172012: 192013: 142014: 62015: 122016: 72017: 1
2007high 23 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNI

168in 2016

2007: 82 days median2008: 64 days median2009: 86 days median2010: 74 days median2011: 111 days median2012: 75 days median2013: 77 days median2014: 104 days median2015: 54 days median2016: 168 days median
2007high 168 (2016) · low 54 (2015)2026

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

Recalls per year · MNI

1in 2018

2007: 262008: 82009: 32010: 12012: 12013: 42015: 12018: 1
2007high 26 (2007) · low 0 (2011)2026

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

Adverse event reports per year · MNI

80in 2025

2007: 832008: 1082009: 1382010: 1262011: 1462012: 2002013: 8242014: 3012015: 2602016: 1172017: 2472018: 1342019: 1882020: 1152021: 2702022: 2142023: 1222024: 1142025: 80
2007high 824 (2013) · low 80 (2025)2025

MAUDE reports naming product code MNI, 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
200720822683
200823648108
200918863138
201016741126
2011171110146
201219751200
201314774824
201461040301
201512541260
201671680117
20171—0247
20180—1134
20190—0188
20200—0115
20210—0270
20220—0214
20230—0122
20240—0114
20250—080
20260—0—

What is it indicated for?

When used as a pedicle screw fixation system in the non-cervical spine of skeletally mature patients (MNI), The AMT SpinalTMSystem is intended for immobilization and stabilization of spinal segments 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) severe degenerative spondylolithesis with objective evidence of neurological impairment, (2) fracture, (3)…

Read the full statement (147 words)

When used as a pedicle screw fixation system in the non-cervical spine of skeletally mature patients (MNI), The AMT SpinalTMSystem is intended for immobilization and stabilization of spinal segments 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) severe degenerative spondylolithesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudoarthrosis).

The AMT SpinalTMSystem is intended for skeletally mature patients (MNH): (1) having severe spondylolithesis (Grades 3 and 4) at the L5S1 vertebral joint; (2) who are receiving fusion by autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

Indications for use as stated in the FDA summary.

Also cleared against K002059

4 other devices cite the same predicate.

  • K083178Solas Anatomix Spinal SystemBiotechni America Spine Group, Inc. · 2009
  • K031585U&I, Optima, Spinal SystemU&I Corp., America · 20035 recalls
  • K024096Optima, Spinal SystemU&I Corp., America · 20033 recalls
  • K020279Forex Corporation, Optima, Spinal SystemForex Corp. · 20024 recalls

More from Micron Precision Engineering, Inc.

2 FDA decisions under this applicant name. See the company

  • K002059Amt Spinal SystemMicron Precision Engineering, Inc. · 2000

Recent decisions in MNI

The MNI category page

  • K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017
  • K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 2016
  • K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc. · 2016
  • K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A. · 2016
  • K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. · 2016

https://510kreport.com/device/K022768 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022768: Amt Polyaxial Pedicle Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022768

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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