510(k) · Cleared
ClearedPinehurst Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signature Orthopaedics Pty, Ltd. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jan 17, 2019 as substantially equivalent to K143279 (L&K BIOMED Co., Ltd., 2015) and 8 other predicates after a 258-day review. Its family tree reaches back 8 generations to 1992.
- Decided
- Jan 17, 2019
- Review
- 258 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 8 generations to K922087 (1992). 53 ancestors in all. 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 deviceK181190 Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd. · 2019
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) | K181190 | Pinehurst Anterior Cervical Plate System | Signature Orthopaedics Pty, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 5 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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? (9)
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 |
|---|---|---|---|
| * | K143279 | LnK Anterior Cervical Plate SystemSummary page 4…) Predicate Devices: Primary Predicate • L&K Biomed LnK Anterior Cervical Plate System (K143279) Additional Predicate • Spinal Concepts SC-AccFix Thinline Anterior… | 2015 |
| * | K013979 | SC-Acufix Thinline Anterior Cervical Plate SystemSummary page 4…Additional Predicate • Spinal Concepts SC-AccFix Thinline Anterior Cervical Plate System (K013979) • Orthofix CETRA Anterior Cervical Plate System (K162638)… | 2002 |
| * | K162638 | CETRA Anterior Cervical Plate SystemSummary page 4…Plate System (K013979) • Orthofix CETRA Anterior Cervical Plate System (K162638) • Globus Medical PROVIDENCE Anterior Cervical Plate System (… | 2016 |
| * | K070775 | Modification to: Providence Anterior Cervical Plate SystemSummary page 4…(K162638) • Globus Medical PROVIDENCE Anterior Cervical Plate System (K070775) • DePuy Synthes CSLP System (K945700, K000536, K000742, K030… | 2007 |
| * | K945700 | Synthes (Usa) Anterior Cervical Vertebrae Plate SystemSummary page 4…• Globus Medical PROVIDENCE Anterior Cervical Plate System (K070775) • DePuy Synthes CSLP System (K945700, K000536, K000742, K030866) • Signature Orthopaedics NOOSA An… | 1995 |
| * | K000536 | Synthes Anterior CSLP SystemSummary page 4…bus Medical PROVIDENCE Anterior Cervical Plate System (K070775) • DePuy Synthes CSLP System (K945700, K000536, K000742, K030866) • Signature Orthopaedics NOOSA Anterior Lu… | 2000 |
| * | K000742 | Synthes Anterior CSLP SystemSummary page 4…e System (K070775) • DePuy Synthes CSLP System (K945700, K000536, K000742, K030866) • Signature Orthopaedics NOOSA Anterior Lumbar Plate… | 2000 |
| * | K030866 | Synthes Anterior CSLP SystemSummary page 4…System (K070775) • DePuy Synthes CSLP System (K945700, K000536, K000742, K030866) • Signature Orthopaedics NOOSA Anterior Lumbar Plate System… | 2003 |
| * | K163625 | NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS…Summary page 4…K000742, K030866) • Signature Orthopaedics NOOSA Anterior Lumbar Plate System (K163625) Device Description: The Signature Orthopaedics’ Pinehurst Anterior Cervical Plate System’s components are… | 2017 |
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 27 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 7 of the 53 ancestors have a recall of any class.
- 2 other devices also cite its predicate K143279.
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. 2019, 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 Signature Orthopaedics Pinehurst Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilisation and stabilisation of the spine as an adjunct to fusions in patients with:
• Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
• Spondylolisthesis;
• Trauma (I.e fracture or dislocations);
• Tumors;
• Deformity (defined as kyphosis, lordosis, or scoliosis);
• Pseudoarthrosis;
• Failed previous fusion;
• Spinal stenosis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181190 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181190: Pinehurst Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181190
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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