510(k) · Cleared
Cleared3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix US, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Feb 11, 2022 as substantially equivalent to K020620 (Blackstone Medical, Inc., 2002) and 5 other predicates after a 253-day review. Its family tree reaches back 8 generations to 1992.
- Decided
- Feb 11, 2022
- Review
- 253 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 8 generations to K922087 (1992). 54 ancestors in all, the oldest K761228 (1976). No later device cites it as a predicate yet.
- Root · 8 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 7 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 6 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- 5 generations backK012184 Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2002
- 4 generations backK030595 Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2003
- 3 generations backK050892 Hallmarktm Anterior Cervical Plate SystemBlackstone Medical, Inc. · 2005 · Recalled
- 2 generations backK100614 Hallmark Anterior Cervcial Plate System, Hallmark Five-Level…Blackstone Medical, Inc. · 2010
- 1 generation backK162638 CETRA Anterior Cervical Plate SystemOrthofix, Inc. · 2016
- This deviceK211712 3° Anterior Cervical Plating System, Reliant Anterior Cervical…Orthofix US, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −7 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −6 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| −5 | K012184 | Blackstone Iii Anterior Cervical Plating System | Blackstone Medical, Inc. | 2002 | — |
| −4 | K030595 | Blackstone Fusion Anterior Cervical Plating System | Blackstone Medical, Inc. | 2003 | — |
| −3 | K050892 | Hallmarktm Anterior Cervical Plate System | Blackstone Medical, Inc. | 2005 | 2 |
| −2 | K100614 | Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates | Blackstone Medical, Inc. | 2010 | — |
| −1 | K162638 | CETRA Anterior Cervical Plate System | Orthofix, Inc. | 2016 | — |
| 0 (this device) | K211712 | 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System… | Orthofix US, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2014 | 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? (6)
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 |
|---|---|---|---|
| * | K020620 | Blackstone Iii Degree Anterior Cervical Plating System (Plate Washer)Summary page 10…Plate System Class II per 21 CFR § 888.3060 Review Panel: Orthopedic Device Panel Predicate Devices: 3° Anterior Cervical Plating System (K020620) Reliant Anterior Cervical Plating System (K030595) Unity Lumbosacral Fixation Sy… | 2002 |
| * | K030595 | Blackstone Fusion Anterior Cervical Plating SystemSummary page 10…Orthopedic Device Panel Predicate Devices: 3° Anterior Cervical Plating System (K020620) Reliant Anterior Cervical Plating System (K030595) Unity Lumbosacral Fixation System (K061229) Hallmark Anterior Plate System (K100… | 2003 |
| * | K061229 | Unity LX Anterolateral Lumbar Plate Fixation SystemSummary page 10…r Cervical Plating System (K020620) Reliant Anterior Cervical Plating System (K030595) Unity Lumbosacral Fixation System (K061229) Hallmark Anterior Plate System (K100614) NewBridge Laminoplasty Fixation System… | 2006 |
| * | K100614 | Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesSummary page 10…nt Anterior Cervical Plating System (K030595) Unity Lumbosacral Fixation System (K061229) Hallmark Anterior Plate System (K100614) NewBridge Laminoplasty Fixation System (K043338) CETRA Anterior Cervical Plate S… | 2010 |
| * | K043338 | Blakstone Laminoplasty Fixation SystemSummary page 10…ty Lumbosacral Fixation System (K061229) Hallmark Anterior Plate System (K100614) NewBridge Laminoplasty Fixation System (K043338) CETRA Anterior Cervical Plate System (K162638) Reason for 510(k) Submission: Orthofix is submitting thi… | 2005 |
| * | K162638 | CETRA Anterior Cervical Plate SystemSummary page 10…rk Anterior Plate System (K100614) NewBridge Laminoplasty Fixation System (K043338) CETRA Anterior Cervical Plate System (K162638) Reason for 510(k) Submission: Orthofix is submitting this Traditional 510(k) premarket notification for the addition of MR Cond… | 2016 |
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 30 years and passes through 6 companies; a new generation was cleared every 5.0 years on median.
- 6 of the 54 ancestors have a recall of any class.
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. 2022, 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?
The 3° Anterior Cervical Plating System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include: 1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies). 2. Spondylolisthesis 3. Fracture 4. Spinal stenosis 5. Deformities (i.e., scoliosis, kyphosis, and/or lordosis) 6. Tumor 7. Pseudoarthrosis 8. Revision…
Read the full statement (487 words)
The 3° Anterior Cervical Plating System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
2. Spondylolisthesis
3. Fracture
4. Spinal stenosis
5. Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
6. Tumor
7. Pseudoarthrosis
8. Revision of previous surgery
The Reliant Anterior Cervical Plating System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
2. Spondylolisthesis
3. Fracture
4. Spinal stenosis
5. Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
6. Tumor
7. Pseudoarthrosis
8. Revision of previous surgery
The Unity Lumbosacral Fixation Plate is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral (L5-S1) level below the bifurcation of the vascular structures. The Unity LX Lumbar Fixation Plate is indicated for use as an anteriorly or anterolaterally placed supplemental fixation device for the lumbar region of the spine above the bifurcation of the vascular structures. When properly used, the system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include:
1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
2. Pseudoarthrosis.
3. Spondylolysis.
4. Spondylolisthesis.
5. Fracture.
6. Neoplastic disease.
7. Unsuccessful previous fusion surgery.
8. Lordotic deformities of the spine.
9. Idiopathic thoracolumbar or lumbar scoliosis.
10. Deformities (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
11. Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic obliquity.
The Hallmark Anterior Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
2. Spondylolisthesis
3. Fracture
4. Spinal stenosis
5. Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
6. Tumor
7. Pseudoarthrosis
8. Revision of previous surgery
The NewBridge Laminoplasty Fixation System is indicated for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The system holds or buttresses the allograft in place in order to prevent expulsion of the allograft or impingement of the spinal cord.
The CETRA Anterior Cervical Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
2. Spondylolisthesis
3. Fracture
4. Spinal stenosis
5. Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
6. Tumor
7. Pseudoarthrosis
8. Revision of previous surgery
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211712 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211712: 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211712
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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