510(k) Report

510(k) · Cleared

Cleared

Single Use Perpos PLS System, 4.5 Bone-Lok PLS Implant

K082795510(k) TraditionalCleared Dec 12, 200880-day reviewClass U

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

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

Cleared on Dec 12, 2008 as substantially equivalent to K062391 (Triage Medical, Inc., 2006) and 2 other predicates after an 80-day review. Its family tree reaches back 3 generations to 2002. 8 later devices descend from it.

Decided
Dec 12, 2008
Review
80 days
Class
Class U
Product code
MRW
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K020411 (2002). 7 ancestors in all, the oldest K953076 (1997). 8 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2005: 1 other ancestor2001: 1 other ancestor1997: 1 other ancestor2010: 2 descendants cleared2009: 1 descendant cleared2011: 1 descendant cleared2024: 2 descendants cleared2019: 1 descendant cleared2025: 1 descendant clearedK020411 · 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 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 3 descendants K062391 · 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. · 20020
  1. Root · 3 generations backK020411 Nuvasive Triad Facet Screw SystemNuvasive, Inc. · 2002
  2. 2 generations backK043351 4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S…Triage Medical, Inc. · 2005 · Recalled
  3. 1 generation backK062391 Disposable Posterior Lumbar Stabilization Procedure Kit, Models…Triage Medical, Inc. · 2006 · Recalled
  4. This deviceK082795 Single Use Perpos PLS System, 4.5 Bone-Lok PLS ImplantInterventional Spine, Inc. · 2008
  5. Descendant · cites it directly · 4 of its ownK102438 Primalok Facet Fixation SystemOsteomed LP · 2010 · Recalled
  6. Descendant · cites it directly · 3 of its ownK090767 Perpos FCD-2 System (Single Patient Use), Anchor, StabilizerInterventional Spine, Inc. · 2009
  7. Descendant · 2 generations on · 2 of its ownK240085 zLOCK Lumbar Facet Fixation SystemZygofix, Ltd. · 2024
  8. Descendant · 2 generations on · 1 of its ownK101762 Viper F2 Facet Fixation SystemDepuy Spine, Inc. · 2010
  9. Descendant · 3 generations on · 0 of its ownK242527 The Karma® Fixation SystemSpinal Elements, Inc. · 2025

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2009: 12010: 22011: 12019: 12024: 22025: 1
2009high 2 (2010) · low 0 (2012)2026

Most influential descendants

Showing 5 of 8 · See all
  • K102438Primalok Facet Fixation SystemOsteomed LP · 2010 · cites it directly4descendants
  • K090767Perpos FCD-2 System (Single Patient Use), Anchor, StabilizerInterventional Spine, Inc. · 2009 · cites it directly3descendants
  • K240085zLOCK Lumbar Facet Fixation SystemZygofix, Ltd. · 2024 · 2 generations on2descendants
  • K101762Viper F2 Facet Fixation SystemDepuy Spine, Inc. · 2010 · 2 generations on1descendant
  • K242527The Karma® Fixation SystemSpinal Elements, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K020411Nuvasive Triad Facet Screw SystemNuvasive, Inc.2002—
−2K0433514.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or NTriage Medical, Inc.20051
−1K062391Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 and…Triage Medical, Inc.20061
0 (this device)K082795Single Use Perpos PLS System, 4.5 Bone-Lok PLS ImplantInterventional Spine, Inc.2008—
+1K102438Primalok Facet Fixation SystemOsteomed LP20101
+1K090767Perpos FCD-2 System (Single Patient Use), Anchor, StabilizerInterventional Spine, Inc.2009—
+2K240085zLOCK Lumbar Facet Fixation SystemZygofix, Ltd.2024—
+2K101762Viper F2 Facet Fixation SystemDepuy Spine, Inc.2010—
+3K242527The Karma® Fixation SystemSpinal Elements, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200110
200510
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201020
201110
201910
202420
202510
FIG. 1 — Lineage of K082795, 2002–2025Source: 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
Get a 510(k) Report

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
*K062391Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 and 9045-02…
Summary page 1
…Plastic Surgery G. Device Class: Unclassified Predicate Devices Triage Medical Disposable Posterior Lumbar Stabilization (PLS) Procedure Kit) K062391 Triage Medical BONE-LOK® 4.5mm Facet Screw and BONE-LOK ® FS Instrument Kit K043351. TranS1 ® Facet Screws K073515 DEVICE DESCR…
Triage Medical, Inc.20061
*K0433514.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or N
Summary page 1
…evices Triage Medical Disposable Posterior Lumbar Stabilization (PLS) Procedure Kit) K062391 Triage Medical BONE-LOK® 4.5mm Facet Screw and BONE-LOK ® FS Instrument Kit K043351. TranS1 ® Facet Screws K073515 DEVICE DESCRIPTION The 4.5mm BONE-LOK® PLS Implant is a double-helix screw with a compression- l…
Triage Medical, Inc.20051
*K073515TRANS1 Facet Screw
Summary page 1
…le Posterior Lumbar Stabilization (PLS) Procedure Kit) K062391 Triage Medical BONE-LOK® 4.5mm Facet Screw and BONE-LOK ® FS Instrument Kit K043351. TranS1 ® Facet Screws K073515 DEVICE DESCRIPTION The 4.5mm BONE-LOK® PLS Implant is a double-helix screw with a compression- locking collar made of medical g…
Trans1 Incorporated2008—

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K102438Primalok Facet Fixation SystemOsteomed LP20104
K090767Perpos FCD-2 System (Single Patient Use), Anchor, StabilizerInterventional Spine, Inc.20093

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 6 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
  • 2 of the 7 ancestors have a recall of any class.
  • Of its descendants, K102438 (Osteomed LP, 2010) has gone furthest, with 4 descendants of its own.

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. 2008, 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 4.5mm BONE-LOK® PLS IMPLANT is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis, or failed previous fusion. The intended use of the 4.5mm BONE-LOK® PLS Implant is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The…

Read the full statement (161 words)

The 4.5mm BONE-LOK® PLS IMPLANT is indicated for spondylolisthesis, spondylolysis,

degenerative disc disease (DDD) as defined by back pain of discogenic origin as confirmed

by radiographic studies, degeneration of the facets with instability and fracture,

pseudoarthrosis, or failed previous fusion.

The intended use of the 4.5mm BONE-LOK® PLS Implant is to stabilize the spine as an

aid to fusion through bilateral immobilization of the facet joints. The 4.5mm BONE-LOK®

PLS Implant may be used to supplement legally marketed anterior fusion products in order

to create an anterior/posterior fixation construction as an aid to fusion. The screws are

inserted posteriorly through the superior side of the facet, across the facet joint and into the

pedicle. The 4.5mm BONE-LOK® PLS Implant is intended for lumbar bilateral facet

fixation, with or without bone graft, at single or multiple levels from L1 to S1. The intended

use of the associated manual surgical instruments is to aid in the implantation of the

4.5mm BONE-LOK® PLS Implant.

Indications for use as stated in the FDA summary.

More from Interventional Spine, Inc.

8 FDA decisions under this applicant name. See the company

  • K160464Opticage (R) Expandable Interbody Fusion DeviceInterventional Spine, Inc. · 20162 recalls
  • K152156Opticage Expandable Interbody Fusion DeviceInterventional Spine, Inc. · 20152 recalls
  • K140716Opticage Expandable Interbody Fusion DeviceInterventional Spine, Inc. · 2014
  • K133583Opticage Interbody Fusion Device, Model Series 9070Interventional Spine, Inc. · 2014
  • K132479Opticage Interbody Fusion Device, Model 9080-00Interventional Spine, Inc. · 2013

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/K082795 · printed Nov 5, 2026

Cite this page

510(k) Report. “K082795: Single Use Perpos PLS System, 4.5 Bone-Lok PLS Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082795

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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