510(k) · Cleared
Cleared4CIS® Pinehurst Anterior Cervical Plate system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solco Biomedical Co., Ltd. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jan 16, 2019 as substantially equivalent to K141632 (Medtronic Sofamor Danek USA, Inc., 2014) and 3 other predicates after a 127-day review. Its family tree reaches back 8 generations to 1995. 1 later device descends from it.
- Decided
- Jan 16, 2019
- Review
- 127 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K953730 (1995). 23 ancestors in all, the oldest K792352 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
- 7 generations backK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
- 6 generations backK040655 Swift Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004
- 5 generations backK072546 Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007
- 4 generations backK080646 C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 2008 · Recalled
- 3 generations backK081038 Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2008 · Recalled
- 2 generations backK130640 Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 1 generation backK141632 Zevo (TM) Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- This deviceK182489 4CIS® Pinehurst Anterior Cervical Plate systemSolco Biomedical Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK223321 Omnia Medical Coupler-C Anterior Cervical PlateOmnia Medical, LLC · 2023
Most influential descendants
Showing 1 of 1 · See all- K223321Omnia Medical Coupler-C Anterior Cervical PlateOmnia Medical, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K953730 | Codman Anterior Cervical Plate System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −7 | K013877 | Codman Slim-Loc System | Codman & Shurtleff, Inc. | 2001 | — |
| −6 | K040655 | Swift Anterior Cervical Plate System | Depuy Spine, Inc. | 2004 | — |
| −5 | K072546 | Swift Plus Anterior Cervical Plate System | Depuy Spine, Inc. | 2007 | — |
| −4 | K080646 | C-Tek Maxan Anterior Cervical Plate System | Biomet Spine | 2008 | 2 |
| −3 | K081038 | Atlantis Anterior Cervical Plate System | Medtronic Sofamor Danek | 2008 | 3 |
| −2 | K130640 | Atlantis Anterior Cervical Plate System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −1 | K141632 | Zevo (TM) Anterior Cervical Plate System | Medtronic Sofamor Danek USA, Inc. | 2014 | 1 |
| 0 (this device) | K182489 | 4CIS® Pinehurst Anterior Cervical Plate system | Solco Biomedical Co., Ltd. | 2019 | — |
| +1 | K223321 | Omnia Medical Coupler-C Anterior Cervical Plate | Omnia Medical, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K141632 | Zevo (TM) Anterior Cervical Plate SystemSummary page 4…ication Code KWQ Regulatory Class Class II Regulation Number 888.3060 ZevoTM Anterior Cervical Plate System (K141632, SE 12/04/2014) [MEDTRONIC SOFAMOR DANEK USA, INC.] – Primary Predicate… | 2014 |
| * | K792352 | Synthes Cervical Vertabrae PlatesSummary page 4…14) [MEDTRONIC SOFAMOR DANEK USA, INC.] – Primary Predicate Anterior Cervical Spine Locking Plate (CSLP) System (K792352, SE 12/06/1979) [DEPUY SYNTHES] – Additional Predicate Predicate Device A… | 1979 |
| * | K926453 | Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSummary page 4…SE 12/06/1979) [DEPUY SYNTHES] – Additional Predicate Predicate Device Anterior Cervical Spine Locking Plate (CSLP) System (K926453, SE 10/12/1993) [SYNTHES(USA)] – Additional Predicate IST ANTERIOR CERVI… | 1993 |
| * | K072650 | Ist Anterior Cervical Plate SystemSummary page 4…(CSLP) System (K926453, SE 10/12/1993) [SYNTHES(USA)] – Additional Predicate IST ANTERIOR CERVICAL PLATE SYSTEM (K072650, SE 11/28/2007) [INNOVATIVE SPINAL TECHNOLOGIES INC] – Additional Predica… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223321 | Omnia Medical Coupler-C Anterior Cervical Plate | 2023 | 0 |
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 24 years and passes through 7 companies; a new generation was cleared every 3.3 years on median.
- 5 of the 23 ancestors have a recall of any class.
- Of its descendants, K223321 (Omnia Medical, LLC, 2023) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K141632.
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 4CIS® Pinehurst Anterior Cervical Plate system is intended for anterior interbody screw fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) Spondylolisthesis, 3) trauma (including fractures), 4) Spinal Stenosis, 5) tumors, 6) deformity (defined as kyphosis, lordosis, or scoliosis), 7) pseudarthrosis, and/or 8) failed previous fusions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182489 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182489: 4CIS® Pinehurst 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/K182489
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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