510(k) Report

510(k) · Cleared

Cleared

Raptor Facet Fixation System

K110170510(k) TraditionalCleared Nov 28, 2011312-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Alphatec Spine, Inc. · MRW System, Facet Screw Spinal Device

Cleared on Nov 28, 2011 as substantially equivalent to K092464 (Spineology, Inc., 2009) and 4 other predicates after a 312-day review. Its family tree reaches back 5 generations to 2002.

Decided
Nov 28, 2011
Review
312 days
Class
Class U
Product code
MRW
Recalls
None
Predicates
5

Its longest line of descent runs back 5 generations to K020411 (2002). 15 ancestors in all, the oldest K953076 (1997). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2010: 2 other ancestors2009: 1 other ancestor2008: 2 other ancestors2001: 2 other ancestors2000: 1 other ancestor2005: 1 other ancestor1997: 1 other ancestorK020411 · Nuvasive Triad Facet Screw System · Nuvasive, Inc. · 2002K043351 · 4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or N · Triage Medical, Inc. · 2005 · recalledK062391 · Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 and 9045-02; Compression Tool, Model 6113-00 · Triage Medical, Inc. · 2006 · recalledK082795 · Single Use Perpos PLS System, 4.5 Bone-Lok PLS Implant · Interventional Spine, Inc. · 2008K090767 · Perpos FCD-2 System (Single Patient Use), Anchor, Stabilizer · Interventional Spine, Inc. · 20091995200020052010
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 3 other ancestors3 generations back: 3 other ancestors K090767 · Perpos FCD-2 System (Single Patient Use), Anchor, Stabilizer · Interventional Spine, Inc. · 2009K082795 · Single Use Perpos PLS System, 4.5 Bone-Lok PLS Implant · Interventional Spine, Inc. · 2008K062391 · Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 and 9045-02; Compression Tool, Model 6113-00 · Triage Medical, Inc. · 2006 · recalledK043351 · 4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or N · Triage Medical, Inc. · 2005 · recalledK020411 · Nuvasive Triad Facet Screw System · Nuvasive, Inc. · 2002−50
  1. Root · 5 generations backK020411 Nuvasive Triad Facet Screw SystemNuvasive, Inc. · 2002
  2. 4 generations backK043351 4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S…Triage Medical, Inc. · 2005 · Recalled
  3. 3 generations backK062391 Disposable Posterior Lumbar Stabilization Procedure Kit, Models…Triage Medical, Inc. · 2006 · Recalled
  4. 2 generations backK082795 Single Use Perpos PLS System, 4.5 Bone-Lok PLS ImplantInterventional Spine, Inc. · 2008
  5. 1 generation backK090767 Perpos FCD-2 System (Single Patient Use), Anchor, StabilizerInterventional Spine, Inc. · 2009
  6. This deviceK110170 Raptor Facet Fixation SystemAlphatec Spine, Inc. · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K020411Nuvasive Triad Facet Screw SystemNuvasive, Inc.2002—
−4K0433514.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or NTriage Medical, Inc.20051
−3K062391Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 and…Triage Medical, Inc.20061
−2K082795Single Use Perpos PLS System, 4.5 Bone-Lok PLS ImplantInterventional Spine, Inc.2008—
−1K090767Perpos FCD-2 System (Single Patient Use), Anchor, StabilizerInterventional Spine, Inc.2009—
0 (this device)K110170Raptor Facet Fixation SystemAlphatec Spine, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200010
200120
200510
200820
200910
201020
FIG. 1 — Lineage of K110170, 2002–2011Source: 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 MRW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MRW device

  1. #1 K230840 PMT Facet Fixation System, Lumbar (PMT FFS-LX)score 26.0 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (5)

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
*K092464Spineology Facet Screw
Summary page 2
…ptomatic or which may cause secondary instability or deformity Raptor T" Facet Fixation System Predicate Devices: Capture Tm Facet Fixation System K092464 Interventional Spine, Inc.PERPOS FCD-2 System K090767 Osteomed Spine Inc. PrimaL-OK Facet Fixation System K102438 X-Spine Systems…
Spineology, Inc.2009—
*K090767Perpos FCD-2 System (Single Patient Use), Anchor, Stabilizer
Summary page 2
…or deformity Raptor T" Facet Fixation System Predicate Devices: Capture Tm Facet Fixation System K092464 Interventional Spine, Inc.PERPOS FCD-2 System K090767 Osteomed Spine Inc. PrimaL-OK Facet Fixation System K102438 X-Spine Systems Inc. Fixcet Spinal Fixation Screw System K100154 Spin…
Interventional Spine, Inc.2009—
*K102438Primalok Facet Fixation System
Summary page 2
…Predicate Devices: Capture Tm Facet Fixation System K092464 Interventional Spine, Inc.PERPOS FCD-2 System K090767 Osteomed Spine Inc. PrimaL-OK Facet Fixation System K102438 X-Spine Systems Inc. Fixcet Spinal Fixation Screw System K100154 SpineFrontier Chameleon Fixation System k071420 Technological…
Osteomed LP20101
*K100154Fixcet Spinal Facet Screw System
Summary page 2
…nterventional Spine, Inc.PERPOS FCD-2 System K090767 Osteomed Spine Inc. PrimaL-OK Facet Fixation System K102438 X-Spine Systems Inc. Fixcet Spinal Fixation Screw System K100154 SpineFrontier Chameleon Fixation System k071420 Technological Characteristics Comparison: The RaptorT m Facet Fixation System…
X-Spine Systems, Inc.2010—
*K071420Chameleon Fixation System
Summary page 2
…0767 Osteomed Spine Inc. PrimaL-OK Facet Fixation System K102438 X-Spine Systems Inc. Fixcet Spinal Fixation Screw System K100154 SpineFrontier Chameleon Fixation System k071420 Technological Characteristics Comparison: The RaptorT m Facet Fixation System is substantially equivalent to the referenced de…
Spinefrontier, Inc.20081

Also cleared against K092464: 2 other devices →

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 9 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
  • 4 of the 15 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K092464.

How does its category compare?

All MRW devices

MRW System, Facet Screw Spinal Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · MRW

7in 2025

2008: 32009: 62010: 62011: 32012: 42013: 72015: 22016: 22017: 12018: 22019: 32022: 32023: 32024: 72025: 72026 (partial year): 5
2007high 7 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MRW

97in 2025

2008: 88 days median2009: 89 days median2010: 108 days median2011: 122 days median2012: 119 days median2013: 110 days median2019: 90 days median2022: 252 days median2023: 190 days median2024: 50 days median2025: 97 days median2026 (partial year): 169 days median
2007high 252 (2022) · low 50 (2024)2026

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

Recalls per year · MRW

3in 2011

2011: 3
2007high 3 (2011) · low 0 (2007)2026

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

Adverse event reports per year · MRW

3in 2025

2007: 12009: 22010: 72011: 622012: 62013: 42014: 12015: 22016: 12017: 42018: 42021: 12023: 12024: 22025: 3
2007high 62 (2011) · low 0 (2008)2025

MAUDE reports naming product code MRW, 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
20070—01
200838800
200968902
2010610807
20113122362
2012411906
2013711004
20140—01
20152—02
20162—01
20171—04
20182—04
201939000
20200—00
20210—01
2022325200
2023319001
202475002
202579703
202651690—

What is it indicated for?

The Raptor Tm Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. Raptor Tm Facet Fixation System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels from Li-Si inclusive. The Raptor Tm Facet Fixation System is…

Read the full statement (139 words)

The Raptor Tm Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. Raptor Tm Facet Fixation System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels from Li-Si inclusive. The Raptor Tm Facet Fixation System is indicated for treatment of any or all of the following:

- degenerative disc disease (ODD) as defined by back pain of discogenic origins confirmed by history and radiographic studies

- degenerative disease of the facets with instability

- trauma (i.e. fracture or dislocation)

- spondylolisthesis

- spondylolysis

- pseudoarthrosis and failed previous fusion which are symptomatic or which may cause secondary instability or deformity

Indications for use as stated in the FDA summary.

Also cleared against K092464

2 other devices cite the same predicate.

  • K101762Viper F2 Facet Fixation SystemDepuy Spine, Inc. · 2010
  • K101284Facet Screw SystemNuvasive, Inc. · 2010

More from Alphatec Spine, Inc.

96 FDA decisions under this applicant name. See the company

  • K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX…Alphatec Spine, Inc. · 2026
  • K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc. · 2026
  • K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc. · 2026
  • K253615Invictus Bands SystemAlphatec Spine, Inc. · 2026
  • K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)Alphatec Spine, Inc. · 2026

Recent decisions in MRW

The MRW category page

  • K262618Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026
  • K261209Ion-LSurGenTec, LLC · 2026
  • K253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc. · 2026
  • K253432DiversiVy™ Facet Screw SystemVy Spine, LLC · 2026
  • K251714Ion-CSurGenTec, LLC · 2026

https://510kreport.com/device/K110170 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110170: Raptor Facet Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110170

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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