510(k) Report

510(k) · Cleared

Cleared

Acme Spine System - Series 6000, 7000, Monoaxial and Polyaxial Screw System

K001044510(k) TraditionalCleared Nov 3, 2000217-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

Acme Spine, LLC · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Nov 3, 2000 after a 217-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.

Decided
Nov 3, 2000
Review
217 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
0

5 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2016: 2 descendants cleared2024: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK001044 Acme Spine System - Series 6000, 7000, Monoaxial and Polyaxial Screw…Acme Spine, LLC · 2000
  2. Descendant · cites it directly · 4 of its ownK102995 Talon Spinal SystemSpine360 · 2011
  3. Descendant · 2 generations on · 1 of its ownK241494 Pantheon Pedicle Screw and Iliac Bolt Fixation SystemPantheon Spinal · 2024
  4. Descendant · 3 generations on · 0 of its ownK252219 Cervical Interbody and VBR Fusion SystemSync Surgical · 2026
  5. Descendant · 2 generations on · 0 of its ownK152920 Savannah-T® Pedicle Screw SystemAmendia, Inc. · 2016 · Recalled
  6. Descendant · 2 generations on · 0 of its ownK153152 Syzygy Stabilization SystemAmendia, Inc. · 2016 · Recalled

Most influential descendants

Showing 5 of 5 · See all
  • K102995Talon Spinal SystemSpine360 · 2011 · cites it directly4descendants
  • K241494Pantheon Pedicle Screw and Iliac Bolt Fixation SystemPantheon Spinal · 2024 · 2 generations on1descendant
  • K252219Cervical Interbody and VBR Fusion SystemSync Surgical · 2026 · 3 generations on0descendants
  • K152920Savannah-T® Pedicle Screw SystemAmendia, Inc. · 2016 · 2 generations on0descendants
  • K153152Syzygy Stabilization SystemAmendia, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001044Acme Spine System - Series 6000, 7000, Monoaxial and Polyaxial Screw SystemAcme Spine, LLC2000—
+1K102995Talon Spinal SystemSpine3602011—
+2K241494Pantheon Pedicle Screw and Iliac Bolt Fixation SystemPantheon Spinal2024—
+3K252219Cervical Interbody and VBR Fusion SystemSync Surgical2026—
+2K152920Savannah-T® Pedicle Screw SystemAmendia, Inc.20161
+2K153152Syzygy Stabilization SystemAmendia, Inc.20162

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201620
202410
202610
FIG. 1 — Lineage of K001044, 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? (5)

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

NumberDeviceApplicantDecidedDescendants
K102995Talon Spinal SystemSpine36020114

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, K102995 (Spine360, 2011) has gone furthest, with 4 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 Acme Spine, LLC

2 FDA decisions under this applicant name. See the company

  • K071824Acme Talon Pedicle ScrewAcme Spine, LLC · 2007

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/K001044 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001044: Acme Spine System - Series 6000, 7000, Monoaxial and Polyaxial 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/K001044

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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