510(k) Report

510(k) · Cleared

Cleared

PedFuse Pedicle Screw System

K143377510(k) SpecialCleared Feb 12, 201579-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

Spinefrontier, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Feb 12, 2015 as substantially equivalent to K133153 (Spinefrontier, Inc., 2014) and 2 other predicates after a 79-day review. Its family tree reaches back 10 generations to 1995.

Decided
Feb 12, 2015
Review
79 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
3

Its longest line of descent runs back 10 generations to K951116 (1995). 103 ancestors in all, the oldest K901587 (1990). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2009: 2 other ancestors2011: 1 other ancestor2010: 1 other ancestor2006: 6 other ancestors2005: 9 other ancestors2000: 8 other ancestors1997: 3 other ancestors2008: 3 other ancestors2007: 6 other ancestors2004: 12 other ancestors2003: 8 other ancestors2002: 6 other ancestors1999: 4 other ancestors1993: 2 other ancestors1992: 5 other ancestors1990: 2 other ancestors2001: 4 other ancestors1998: 5 other ancestors1996: 3 other ancestors1995: 2 other ancestors1994: 1 other ancestorReference device: K071420 · Chameleon Fixation System · Spinefrontier, Inc. · 2008 · recalledK951116 · Acromed Pedicle Screw · Acromed Corp. · 1995K963639 · Acromed Pedicle Screw · Acromed Corp. · 1996K982511 · Depuy Motech Moss Miami Spinal Systems · Depuy, Inc. · 1998K030383 · Modification to Moss Miami Spinal System Polyaxial Screws · Depuyacromed · 2003K070245 · Capsure Pedicle Screw System · Spine Wave, Inc. · 2007K081228 · Capsure PS (R) Spine System · Spine Wave, Inc. · 2008K083353 · Capsure (R) PS System · Spine Wave, Inc. · 2008K100605 · Mis System · Spine Wave, Inc. · 2010K123164 · Spinefrontier Pedfuse Pedicle Screw System · Spinefrontier, Inc. · 2013 · recalledK133153 · Spinefrontier Pedfuse Pedicle Screw System · Spinefrontier, Inc. · 2014199019952000200520102015
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 7 other ancestors3 generations back: 27 other ancestors4 generations back: 23 other ancestors5 generations back: 13 other ancestors6 generations back: 10 other ancestors7 generations back: 12 other ancestors K133153 · Spinefrontier Pedfuse Pedicle Screw System · Spinefrontier, Inc. · 2014K123164 · Spinefrontier Pedfuse Pedicle Screw System · Spinefrontier, Inc. · 2013 · recalledK100605 · Mis System · Spine Wave, Inc. · 2010K083353 · Capsure (R) PS System · Spine Wave, Inc. · 2008K081228 · Capsure PS (R) Spine System · Spine Wave, Inc. · 2008K070245 · Capsure Pedicle Screw System · Spine Wave, Inc. · 2007K030383 · Modification to Moss Miami Spinal System Polyaxial Screws · Depuyacromed · 2003K982511 · Depuy Motech Moss Miami Spinal Systems · Depuy, Inc. · 1998K963639 · Acromed Pedicle Screw · Acromed Corp. · 1996K951116 · Acromed Pedicle Screw · Acromed Corp. · 1995−10−50
  1. Root · 10 generations backK951116 Acromed Pedicle ScrewAcromed Corp. · 1995
  2. 6 generations between
  3. 3 generations backK100605 Mis SystemSpine Wave, Inc. · 2010
  4. 2 generations backK123164 Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc. · 2013 · Recalled
  5. 1 generation backK133153 Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc. · 2014
  6. This deviceK143377 PedFuse Pedicle Screw SystemSpinefrontier, Inc. · 2015
Show all 10 generations
  1. Root · 10 generations backK951116 Acromed Pedicle ScrewAcromed Corp. · 1995
  2. 9 generations backK963639 Acromed Pedicle ScrewAcromed Corp. · 1996
  3. 8 generations backK982511 Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998
  4. 7 generations backK030383 Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
  5. 6 generations backK070245 Capsure Pedicle Screw SystemSpine Wave, Inc. · 2007
  6. 5 generations backK081228 Capsure PS (R) Spine SystemSpine Wave, Inc. · 2008
  7. 4 generations backK083353 Capsure (R) PS SystemSpine Wave, Inc. · 2008
  8. 3 generations backK100605 Mis SystemSpine Wave, Inc. · 2010
  9. 2 generations backK123164 Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc. · 2013 · Recalled
  10. 1 generation backK133153 Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc. · 2014
  11. This deviceK143377 PedFuse Pedicle Screw SystemSpinefrontier, Inc. · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K951116Acromed Pedicle ScrewAcromed Corp.1995—
−9K963639Acromed Pedicle ScrewAcromed Corp.1996—
−8K982511Depuy Motech Moss Miami Spinal SystemsDepuy, Inc.1998—
−7K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed2003—
−6K070245Capsure Pedicle Screw SystemSpine Wave, Inc.2007—
−5K081228Capsure PS (R) Spine SystemSpine Wave, Inc.2008—
−4K083353Capsure (R) PS SystemSpine Wave, Inc.2008—
−3K100605Mis SystemSpine Wave, Inc.2010—
−2K123164Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20136
−1K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.2014—
0 (this device)K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199020
199250
199320
199410
199520
199630
199730
199850
199940
200080
200140
200260
200380
2004120
200590
200660
200760
200830
200920
201010
201110
FIG. 1 — Lineage of K143377, 1995–2015Source: 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? (3)

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
*K133153Spinefrontier Pedfuse Pedicle Screw System
Summary page 5
…ss connectors. CHANGE FROM PREVIOUSLY CLEARED SYSTEM The purpose of this submission is to add a component to the SpineFrontier® PedFuse® Pedicle Screw System cleared in K133153, K123164, and K092420. A sliding washer is being added to the system in this submission. INDICATIONS FOR USE The SpineFrontier®…
Spinefrontier, Inc.2014—
*K123164Spinefrontier Pedfuse Pedicle Screw System
Summary page 5
…tors. CHANGE FROM PREVIOUSLY CLEARED SYSTEM The purpose of this submission is to add a component to the SpineFrontier® PedFuse® Pedicle Screw System cleared in K133153, K123164, and K092420. A sliding washer is being added to the system in this submission. INDICATIONS FOR USE The SpineFrontier® PedFuse®…
Spinefrontier, Inc.20136
*K092420KRD1 Pedicle Screw System
Summary page 5
…FROM PREVIOUSLY CLEARED SYSTEM The purpose of this submission is to add a component to the SpineFrontier® PedFuse® Pedicle Screw System cleared in K133153, K123164, and K092420. A sliding washer is being added to the system in this submission. INDICATIONS FOR USE The SpineFrontier® PedFuse® Pedicle Scre…
Spinefrontier, Inc.20092
†K071420Chameleon Fixation SystemSpinefrontier, Inc.20081

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?

  • The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
  • 14 of the 103 ancestors have a recall of any class.

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. 2015, this device’s year, is highlighted.

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 SpineFrontier® PedFuse® Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion…

Read the full statement (110 words)

The SpineFrontier® PedFuse® Pedicle Screw System is intended to provide immobilization and

stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of

the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative

spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis,

kyphosis, spinal tumor, and failed previous fusion (Pseudarthrosis).

In addition, the SpineFrontier® PedFuse® Pedicle Screw System is indicated for the treatment of

severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving

fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (L3 to

S1).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Spinefrontier, Inc.

24 FDA decisions under this applicant name. See the company

  • K193106SpineFrontier Lumbar Interbody Fusion Device SystemSpinefrontier, Inc. · 2020
  • K172484A-CIFT SoloFuseSpinefrontier, Inc. · 20181 recall
  • K151198A-CIFT SoloFuseSpinefrontier, Inc. · 2015
  • K142504SpineFrontier Lumbar Interbody Fusion Device SystemSpinefrontier, Inc. · 2015
  • K150017SpineFrontier SIJFuse Sacroiliac Joint Fusion Device SystemSpinefrontier, Inc. · 2015

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/K143377 · printed Nov 4, 2026

Cite this page

510(k) Report. “K143377: PedFuse Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143377

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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