510(k) Report

510(k) · Cleared

Cleared

Acromed Pedicle Screw

K951116510(k) TraditionalCleared Aug 11, 1995154-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 Aug 11, 1995 after a 154-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 416 later devices descend from it.

Decided
Aug 11, 1995
Review
154 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
0

416 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared2019: 19 descendants cleared1998: 1 descendant cleared1996: 1 descendant cleared2003: 1 descendant cleared2016: 20 descendants cleared2007: 8 descendants cleared2012: 11 descendants cleared2009: 9 descendants cleared2020: 23 descendants cleared2008: 9 descendants cleared2010: 6 descendants cleared2014: 19 descendants cleared2013: 18 descendants cleared2024: 39 descendants cleared2006: 1 descendant cleared2004: 1 descendant cleared2017: 23 descendants cleared2015: 22 descendants cleared2018: 28 descendants cleared2022: 27 descendants cleared2005: 2 descendants cleared2023: 41 descendants cleared2021: 19 descendants cleared2025: 37 descendants cleared2026: 28 descendants cleared2011: 2 descendants cleared1995200020052010201520202025
  1. This deviceK951116 Acromed Pedicle ScrewAcromed Corp. · 1995
  2. Descendant · cites it directly · 414 of its ownK963639 Acromed Pedicle ScrewAcromed Corp. · 1996
  3. Descendant · cites it directly · 413 of its ownK982511 Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998
  4. Descendant · 2 generations on · 410 of its ownK030383 Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
  5. Descendant · 3 generations on · 180 of its ownK071890 Zodiac 4.0 Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2007 · Recalled
  6. Descendant · 4 generations on · 170 of its ownK093077 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2009

Showing 5 of 416 descendants. See all descendants

Descendants cleared per year

1996: 11997: 11998: 12003: 12004: 12005: 22006: 12007: 82008: 92009: 92010: 62011: 22012: 112013: 182014: 192015: 222016: 202017: 232018: 282019: 192020: 232021: 192022: 272023: 412024: 392025: 372026: 28
1996high 41 (2023) · low 0 (1999)2026

Most influential descendants

Showing 5 of 416 · See all
  • K963639Acromed Pedicle ScrewAcromed Corp. · 1996 · cites it directly414descendants
  • K982511Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998 · cites it directly413descendants
  • K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003 · 2 generations on410descendants
  • K071890Zodiac 4.0 Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2007 · 3 generations on180descendants
  • K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2009 · 4 generations on170descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951116Acromed Pedicle ScrewAcromed Corp.1995—
+1K963639Acromed Pedicle ScrewAcromed Corp.1996—
+1K982511Depuy Motech Moss Miami Spinal SystemsDepuy, Inc.1998—
+2K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed2003—
+3K071890Zodiac 4.0 Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20071
+4K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
199810
200310
200410
200520
200610
200780
200890
200990
201060
201120
2012110
2013180
2014190
2015220
2016200
2017230
2018280
2019190
2020230
2021190
2022270
2023410
2024390
2025370
2026280
FIG. 1 — Lineage of K951116, 1995–2026Source: 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 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
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? (416)

See all 416

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

NumberDeviceApplicantDecidedDescendants
K963639Acromed Pedicle ScrewAcromed Corp.1996414
K982511Depuy Motech Moss Miami Spinal SystemsDepuy, Inc.1998413
K965102Acromed Pedicle ScrewAcromed Corp.19971
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?

  • Of its descendants, K963639 (Acromed Corp., 1996) has gone furthest, with 414 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 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/K951116 · printed Nov 6, 2026

Cite this page

510(k) Report. “K951116: Acromed 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/K951116

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