510(k) · Cleared
Recalled · 2011Primalok Facet Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed LP · MRW System, Facet Screw Spinal Device
Cleared on Sep 30, 2010 as substantially equivalent to K012773 (Depuyacromed, 2001) and 2 other predicates after a 35-day review. Its family tree reaches back 4 generations to 2002. 4 later devices descend from it. It has been recalled once.
- Decided
- Sep 30, 2010
- Review
- 35 days
- Class
- Class U
- Product code
- MRW
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K020411 (2002). 11 ancestors in all, the oldest K953076 (1997). 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK020411 Nuvasive Triad Facet Screw SystemNuvasive, Inc. · 2002
- 3 generations backK043351 4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S…Triage Medical, Inc. · 2005 · Recalled
- 2 generations backK062391 Disposable Posterior Lumbar Stabilization Procedure Kit, Models…Triage Medical, Inc. · 2006 · Recalled
- 1 generation backK082795 Single Use Perpos PLS System, 4.5 Bone-Lok PLS ImplantInterventional Spine, Inc. · 2008
- This deviceK102438 Primalok Facet Fixation SystemOsteomed LP · 2010
- Descendant · cites it directly · 2 of its ownK240085 zLOCK Lumbar Facet Fixation SystemZygofix, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK242527 The Karma® Fixation SystemSpinal Elements, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK242650 zLOCK Lumbar Facet Fixation SystemZygofix, Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK110170 Raptor Facet Fixation SystemAlphatec Spine, Inc. · 2011
Most influential descendants
Showing 4 of 4 · See all- K240085zLOCK Lumbar Facet Fixation SystemZygofix, Ltd. · 2024 · cites it directly2descendants
- K242527The Karma® Fixation SystemSpinal Elements, Inc. · 2025 · 2 generations on0descendants
- K242650zLOCK Lumbar Facet Fixation SystemZygofix, Ltd. · 2024 · 2 generations on0descendants
- K110170Raptor Facet Fixation SystemAlphatec Spine, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K020411 | Nuvasive Triad Facet Screw System | Nuvasive, Inc. | 2002 | — |
| −3 | K043351 | 4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or N | Triage Medical, Inc. | 2005 | 1 |
| −2 | K062391 | Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 and… | Triage Medical, Inc. | 2006 | 1 |
| −1 | K082795 | Single Use Perpos PLS System, 4.5 Bone-Lok PLS Implant | Interventional Spine, Inc. | 2008 | — |
| 0 (this device) | K102438 | Primalok Facet Fixation System | Osteomed LP | 2010 | — |
| +1 | K240085 | zLOCK Lumbar Facet Fixation System | Zygofix, Ltd. | 2024 | — |
| +2 | K242527 | The Karma® Fixation System | Spinal Elements, Inc. | 2025 | — |
| +2 | K242650 | zLOCK Lumbar Facet Fixation System | Zygofix, Ltd. | 2024 | — |
| +1 | K110170 | Raptor Facet Fixation System | Alphatec Spine, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
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 K230840 PMT Facet Fixation System, Lumbar (PMT FFS-LX)score 26.0 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K012773 | Discovery Facet Screw Fixation SystemSummary page 1…and titanium alloy (Ti-6AI-4V) as described by ASTM F67 and F1 36, respectively. Predicate Devices: Discoveryo Facet Screw (DePuy AcroMed, K012773) ChameleonT' T Fixation System (Spine Frontier, Inc. - K071420) TM… | 2001 |
| * | K071420 | Chameleon Fixation SystemSummary page 1…respectively. Predicate Devices: Discoveryo Facet Screw (DePuy AcroMed, K012773) ChameleonT' T Fixation System (Spine Frontier, Inc. - K071420) TM PERPOS' PLS System, BONE-LOK® Implant (Interventional Spine,… | 2008 |
| * | K082795 | Single Use Perpos PLS System, 4.5 Bone-Lok PLS ImplantSummary page 1…c. - K071420) TM PERPOS' PLS System, BONE-LOK® Implant (Interventional Spine, Inc. - K082795) Page 15 Technological… | 2008 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 7, 2011 | Not classified | Z-0008-2012 | Device Design | Two of the Implant Driver Assembly tips were reported to break during surgery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K240085 (Zygofix, Ltd., 2024) has gone furthest, with 2 descendants of its own.
- 13 other devices also cite its predicate K012773.
How does its category compare?
All MRW devicesMRW System, Facet Screw Spinal Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MRW
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MRW
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRW
3in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRW
3in 2025
MAUDE reports naming product code MRW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 3 | 88 | 0 | 0 |
| 2009 | 6 | 89 | 0 | 2 |
| 2010 | 6 | 108 | 0 | 7 |
| 2011 | 3 | 122 | 3 | 62 |
| 2012 | 4 | 119 | 0 | 6 |
| 2013 | 7 | 110 | 0 | 4 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 3 | 90 | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 3 | 252 | 0 | 0 |
| 2023 | 3 | 190 | 0 | 1 |
| 2024 | 7 | 50 | 0 | 2 |
| 2025 | 7 | 97 | 0 | 3 |
| 2026 | 5 | 169 | 0 | — |
What is it indicated for?
The PrimaLOK™ FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from Li to Si inclusive, It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed…
Read the full statement (165 words)
The PrimaLOK™ FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from Li to Si inclusive, It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, degenerative disease of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedlicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102438: Primalok 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/K102438
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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