510(k) Report

510(k) · Cleared

Cleared

Amt Spinal System

K002059510(k) TraditionalCleared Nov 13, 2000130-day reviewClass II21 CFR 888.3050

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. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Nov 13, 2000 after a 130-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 696 later devices descend from it.

Decided
Nov 13, 2000
Review
130 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
0

696 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2003: 2 descendants cleared2002: 2 descendants cleared2009: 12 descendants cleared2010: 19 descendants cleared2007: 12 descendants cleared2014: 37 descendants cleared2015: 42 descendants cleared2016: 40 descendants cleared2023: 56 descendants cleared2011: 16 descendants cleared2005: 5 descendants cleared2012: 26 descendants cleared2018: 45 descendants cleared2013: 37 descendants cleared2006: 6 descendants cleared2004: 1 descendant cleared2008: 19 descendants cleared2019: 28 descendants cleared2024: 49 descendants cleared2017: 40 descendants cleared2022: 41 descendants cleared2021: 33 descendants cleared2020: 38 descendants cleared2025: 44 descendants cleared2026: 46 descendants cleared200020052010201520202025
  1. This deviceK002059 Amt Spinal SystemMicron Precision Engineering, Inc. · 2000
  2. Descendant · cites it directly · 693 of its ownK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
  3. Descendant · cites it directly · 579 of its ownK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
  4. Descendant · cites it directly · 466 of its ownK024096 Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
  5. Descendant · 2 generations on · 181 of its ownK053573 GSS Pedicle Screw SystemGS Medical Co., Ltd. · 2006
  6. Descendant · 2 generations on · 180 of its ownK033090 Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc. · 2004 · Recalled

Showing 5 of 696 descendants. See all descendants

Descendants cleared per year

2002: 22003: 22004: 12005: 52006: 62007: 122008: 192009: 122010: 192011: 162012: 262013: 372014: 372015: 422016: 402017: 402018: 452019: 282020: 382021: 332022: 412023: 562024: 492025: 442026: 46
2002high 56 (2023) · low 1 (2004)2026

Most influential descendants

Showing 5 of 696 · See all
  • K020279Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · cites it directly693descendants
  • K031585U&I, Optima, Spinal SystemU&I Corp., America · 2003 · cites it directly579descendants
  • K024096Optima, Spinal SystemU&I Corp., America · 2003 · cites it directly466descendants
  • K053573GSS Pedicle Screw SystemGS Medical Co., Ltd. · 2006 · 2 generations on181descendants
  • K033090Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc. · 2004 · 2 generations on180descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002059Amt Spinal SystemMicron Precision Engineering, Inc.2000—
+1K020279Forex Corporation, Optima, Spinal SystemForex Corp.20024
+1K031585U&I, Optima, Spinal SystemU&I Corp., America20035
+1K024096Optima, Spinal SystemU&I Corp., America20033
+2K053573GSS Pedicle Screw SystemGS Medical Co., Ltd.2006—
+2K033090Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc.20041

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200320
200410
200550
200660
2007120
2008190
2009120
2010190
2011160
2012260
2013370
2014370
2015420
2016400
2017400
2018450
2019280
2020380
2021330
2022410
2023560
2024490
2025440
2026460
FIG. 1 — Lineage of K002059, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 KWP? 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
Get a 510(k) Report

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? (696)

See all 696

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

NumberDeviceApplicantDecidedDescendants
K020279Forex Corporation, Optima, Spinal SystemForex Corp.2002693
K031585U&I, Optima, Spinal SystemU&I Corp., America2003579
K024096Optima, Spinal SystemU&I Corp., America2003466
K083178Solas Anatomix Spinal SystemBiotechni America Spine Group, Inc.20090
K022768Amt Polyaxial Pedicle ScrewMicron Precision Engineering, Inc.20020

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, K020279 (Forex Corp., 2002) has gone furthest, with 693 descendants of its own.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWP

9in 2015

2007: 142008: 132009: 122010: 142011: 122012: 182013: 122014: 132015: 9
2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007: 96 days median2008: 50 days median2009: 89 days median2010: 186 days median2011: 67 days median2012: 112 days median2013: 99 days median2014: 138 days median2015: 113 days median
2007high 186 (2010) · low 50 (2008)2026

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

Recalls per year · KWP

2in 2022

2007: 22008: 12009: 232010: 22011: 62012: 12013: 32015: 12016: 32018: 12019: 22022: 2
2007high 23 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWP

494in 2025

2007: 2102008: 5942009: 6822010: 4742011: 7922012: 9182013: 1,0902014: 1,0222015: 1,3482016: 1,3792017: 8642018: 6572019: 5182020: 7962021: 5252022: 3352023: 3322024: 4362025: 494
2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, 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
200714962210
200813501594
2009128923682
2010141862474
201112676792
2012181121918
2013129931,090
20141313801,022
2015911311,348
20160—31,379
20170—0864
20180—1657
20190—2518
20200—0796
20210—0525
20220—2335
20230—0332
20240—0436
20250—0494
20260—0—

More from Micron Precision Engineering, Inc.

2 FDA decisions under this applicant name. See the company

  • K022768Amt Polyaxial Pedicle ScrewMicron Precision Engineering, Inc. · 2002

Recent decisions in KWP

The KWP category page

  • K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2015
  • K150753OASYS SystemStryker Corporation · 2015
  • K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
  • K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
  • K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 20153 recalls

https://510kreport.com/device/K002059 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002059: Amt Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002059

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026