510(k) · Cleared
ClearedPYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2m, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Dec 12, 2018 as substantially equivalent to K172104 (K2m, Inc., 2017) and 3 other predicates after a 93-day review. Its family tree reaches back 8 generations to 1999. 4 later devices descend from it.
- Decided
- Dec 12, 2018
- Review
- 93 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K990745 (1999). 105 ancestors in all, the oldest K792352 (1979). 4 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 7 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 6 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 5 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 4 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 3 generations backK062407 Gateway Thoracolumbar Plate SystemGlobus Medical, Inc. · 2006
- 2 generations backK100061 Cayman Screws Model K2-12-1000-XX, K2-12-1001-XXK2m, Inc. · 2010
- 1 generation backK131533 Cayman MI Plate SystemK2m, Inc. · 2013
- This deviceK182473 PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System…K2m, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK242361 OZARK Cervical Plate System; PYRENEES® Cervical Plate System…Stryker Spine · 2024
- Descendant · cites it directly · 1 of its ownK221728 Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System…Stryker Corporation · 2022
- Descendant · 2 generations on · 0 of its ownK253545 Vulcan Spinal SystemK2m, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK230424 Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical…Omnia Medical, LLC · 2023
Most influential descendants
Showing 4 of 4 · See all- K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine · 2024 · cites it directly1descendant
- K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation · 2022 · cites it directly1descendant
- K253545Vulcan Spinal SystemK2m, Inc. · 2026 · 2 generations on0descendants
- K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −7 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −6 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −5 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −4 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −3 | K062407 | Gateway Thoracolumbar Plate System | Globus Medical, Inc. | 2006 | — |
| −2 | K100061 | Cayman Screws Model K2-12-1000-XX, K2-12-1001-XX | K2m, Inc. | 2010 | — |
| −1 | K131533 | Cayman MI Plate System | K2m, Inc. | 2013 | — |
| 0 (this device) | K182473 | PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK… | K2m, Inc. | 2018 | — |
| +1 | K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal… | Stryker Spine | 2024 | — |
| +1 | K221728 | Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™… | Stryker Corporation | 2022 | — |
| +2 | K253545 | Vulcan Spinal System | K2m, Inc. | 2026 | — |
| +2 | K230424 | Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical… | Omnia Medical, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 6 | 0 |
| 1998 | 3 | 0 |
| 2000 | 10 | 0 |
| 2001 | 5 | 0 |
| 2002 | 6 | 0 |
| 2003 | 7 | 0 |
| 2004 | 9 | 0 |
| 2005 | 7 | 0 |
| 2006 | 5 | 0 |
| 2007 | 6 | 0 |
| 2008 | 6 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 KWQ? 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 KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K172104 | Ozark (tm) Cervical Plate SystemSummary page 7…nen phenolic, Ultem, Radel, polypropylene, acetal copolymer, or silicone in the handles or retractor blades. Primary Predicate: OZARK Cervical Plate System (K2M Inc. — K172104) Additional Predicates: PYRENEES and BLUE RIDGE Cervical Plate Systems (K2M Inc. — K162664 and K113329, respectively), CAYMAN T… | 2017 |
| * | K162664 | Pyrenees Cervical Plate SystemSummary page 7…tractor blades. Primary Predicate: OZARK Cervical Plate System (K2M Inc. — K172104) Additional Predicates: PYRENEES and BLUE RIDGE Cervical Plate Systems (K2M Inc. — K162664 and K113329, respectively), CAYMAN Thoracolumbar and Buttress Plate Systems (K2M Inc. — K131533) Performance Data: MR Compatibi… | 2016 |
| * | K113329 | K2M, Pyrenees Cervical Plate SystemSummary page 7…es. Primary Predicate: OZARK Cervical Plate System (K2M Inc. — K172104) Additional Predicates: PYRENEES and BLUE RIDGE Cervical Plate Systems (K2M Inc. — K162664 and K113329, respectively), CAYMAN Thoracolumbar and Buttress Plate Systems (K2M Inc. — K131533) Performance Data: MR Compatibility testing… | 2012 |
| * | K131533 | Cayman MI Plate SystemSummary page 7…l Predicates: PYRENEES and BLUE RIDGE Cervical Plate Systems (K2M Inc. — K162664 and K113329, respectively), CAYMAN Thoracolumbar and Buttress Plate Systems (K2M Inc. — K131533) Performance Data: MR Compatibility testing per ASTM F2503 was performed. The test results demonstrate that the PYRENEES, BLUE… | 2013 |
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)
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 19 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- 13 of the 105 ancestors have a recall of any class.
- Of its descendants, K242361 (Stryker Spine, 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K172104.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
PYRENEES and BLUE RIDGE Cervical Plate Systems are indicated for use in anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and…
Read the full statement (320 words)
PYRENEES and BLUE RIDGE Cervical Plate Systems are indicated for use in anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).
OZARK Cervical Plate System is indicated for use in anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).
The CAYMAN Buttress Plates are intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications. The CAYMAN Thoracolumbar Plates are indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1-L5) spine and for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures (L5-S1). The Cayman Thoracolumbar Plate System is intended to provide temporary stabilization during fusion using autograph or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities and deformities: a) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), b) pseudoarthrosis, ¢) spondylolysis, d) spondylolisthesis, €) fracture, f) neoplastic disease, g) unsuccessful previous fusion surgery, h) lordotic deformities of the spine, i) thoracolumbar or lumbar scoliosis, j) deformity (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182473 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182473: PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182473
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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