510(k) Report

510(k) · Cleared

Cleared

Acromed Cable/Wire Pedicle Screw

K964007510(k) TraditionalCleared Dec 16, 199670-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

Acromed Corp. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Dec 16, 1996 as substantially equivalent to K951657 (Acromed Corp., 1995) after a 70-day review. Its family tree reaches back 1 generation to 1995. 46 later devices descend from it.

Decided
Dec 16, 1996
Review
70 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K951657 (1995). 46 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2019: 2 descendants cleared2008: 1 descendant cleared2010: 2 descendants cleared2012: 1 descendant cleared2018: 3 descendants cleared2009: 1 descendant cleared2015: 4 descendants cleared2016: 2 descendants cleared2013: 1 descendant cleared2022: 4 descendants cleared2011: 1 descendant cleared2017: 3 descendants cleared2021: 3 descendants cleared2024: 3 descendants cleared2025: 5 descendants cleared2020: 1 descendant cleared2023: 4 descendants cleared2026: 5 descendants clearedK951657 · VSP (Variable Screw Placement) Spinal Fixation System, Pedicle Screw (S), Spine Plate (S), Washer (S) & Nut (S) · Acromed Corp. · 19951995200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 7 descendants3 generations forward: 14 descendants4 generations forward: 11 descendants5 generations forward: 10 descendants6 generations forward: 2 descendants K951657 · VSP (Variable Screw Placement) Spinal Fixation System, Pedicle Screw (S), Spine Plate (S), Washer (S) & Nut (S) · Acromed Corp. · 19950+5
  1. Root · 1 generation backK951657 VSP (Variable Screw Placement) Spinal Fixation System, Pedicle Screw…Acromed Corp. · 1995
  2. This deviceK964007 Acromed Cable/Wire Pedicle ScrewAcromed Corp. · 1996
  3. Descendant · cites it directly · 44 of its ownK081252 Expedium 4.5MM Spine SystemDepuy Spine, Inc. · 2008
  4. Descendant · 2 generations on · 21 of its ownK150417 Astra Spine SystemSpinecraft, LLC · 2015
  5. Descendant · 3 generations on · 12 of its ownK211323 ASTRA Spine SystemSpinecraft, LLC · 2021
  6. Descendant · 2 generations on · 9 of its ownK100757 Tilock Pedicle Screw SystemGenesys Spine · 2010 · Recalled
  7. Descendant · 3 generations on · 8 of its ownK223273 ASTRA Spine SystemSpinecraft, LLC · 2022

Showing 5 of 46 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12010: 22011: 12012: 12013: 12015: 42016: 22017: 32018: 32019: 22020: 12021: 32022: 42023: 42024: 32025: 52026: 5
2008high 5 (2025) · low 0 (2014)2026

Most influential descendants

Showing 5 of 46 · See all
  • K081252Expedium 4.5MM Spine SystemDepuy Spine, Inc. · 2008 · cites it directly44descendants
  • K150417Astra Spine SystemSpinecraft, LLC · 2015 · 2 generations on21descendants
  • K211323ASTRA Spine SystemSpinecraft, LLC · 2021 · 3 generations on12descendants
  • K100757Tilock Pedicle Screw SystemGenesys Spine · 2010 · 2 generations on9descendants
  • K223273ASTRA Spine SystemSpinecraft, LLC · 2022 · 3 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K951657VSP (Variable Screw Placement) Spinal Fixation System, Pedicle Screw (S)…Acromed Corp.1995—
0 (this device)K964007Acromed Cable/Wire Pedicle ScrewAcromed Corp.1996—
+1K081252Expedium 4.5MM Spine SystemDepuy Spine, Inc.2008—
+2K150417Astra Spine SystemSpinecraft, LLC2015—
+3K211323ASTRA Spine SystemSpinecraft, LLC2021—
+2K100757Tilock Pedicle Screw SystemGenesys Spine20101
+3K223273ASTRA Spine SystemSpinecraft, LLC2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201020
201110
201210
201310
201540
201620
201730
201830
201920
202010
202130
202240
202340
202430
202550
202650
FIG. 1 — Lineage of K964007, 1995–2026Source: 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), 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.

TypeNumberDeviceApplicantDecidedRecalls
*K951657VSP (Variable Screw Placement) Spinal Fixation System, Pedicle Screw (S), Spine Plate…
Summary page 2
…= INDICATIONS: PERFORMANCE DATA: SUBSTANTIAL EQUIVALENCE: Kacuco? D o¥2 The AcroMed Cable/Wire Pedicle Screw is designed to be utilized with the ISOLA Spine System (K951657). When used with pedicle screws, the ISOLA implants are intended for use in grade 3 or 4 spondylolisthesis at L5-S1 utilizing a…
Acromed Corp.1995—
*—Harrington Lag Screw
Named without a submission number
—

Also cleared against K951657: 1 other device →

What descends from it? (46)

See all 46

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

NumberDeviceApplicantDecidedDescendants
K081252Expedium 4.5MM Spine SystemDepuy Spine, Inc.200844
K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190

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, K081252 (Depuy Spine, Inc., 2008) has gone furthest, with 44 descendants of its own.
  • 1 other device also cites its predicate K951657.

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 AcroMed Cable/Wire Pedicle Screw is designed to be utilized with the ISOLA Spine System (K951657). When used with pedicle screws, the ISOLA implants are intended for use in grade 3 or 4 spondylolisthesis at L5-S1 utilizing autologous bone graft and intended to be removed after solid fusion is attained. Levels of attachment for the indication range from L3 to the sacrum. The ISOLA Spinal System, when not used with pedicle screws, is intended for hook…

Read the full statement (139 words)

The AcroMed Cable/Wire Pedicle Screw is designed to be utilized with the ISOLA Spine System (K951657). When used with pedicle screws, the ISOLA implants are intended for use in grade 3 or 4 spondylolisthesis at L5-S1 utilizing autologous bone graft and intended to be removed after solid fusion is attained. Levels of attachment for the indication range from L3 to the sacrum.

The ISOLA Spinal System, when not used with pedicle screws, is intended for hook, wire, and/or sacral/iliac screw fixation from T1 to the iliunVsacrum, The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed surgery.

As a whole, the ISOLA Spinal System is imended for T1-sacral fixation. Screw fixation is from L3-S1.

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 K951657

1 other device cites the same predicate.

  • K982511Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998

More from Acromed Corp.

41 FDA decisions under this applicant name. See the company

  • K980485Isola Spinal SystemAcromed Corp. · 1998
  • K981714Timx Low Back System Titanium MX Rod Based Low Back SystemAcromed Corp. · 1998
  • K981113Pediatric PRCAcromed Corp. · 1998
  • K981274Acromed Timx Plate Based Low Back SystemAcromed Corp. · 1998
  • K980228University Plate Anterior SystemAcromed Corp. · 1998

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/K964007 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964007: Acromed Cable/Wire Pedicle Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964007

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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