510(k) · Cleared
ClearedTangis Anterior Cervical Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nvision Biomedical Technologies, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Sep 2, 2016 as substantially equivalent to K151553 (Osteomed Implantes, Ltda, 2016) and 2 other predicates after a 92-day review. Its family tree reaches back 6 generations to 1995. 8 later devices descend from it.
- Decided
- Sep 2, 2016
- Review
- 92 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K953730 (1995). 33 ancestors in all, the oldest K914362 (1992). 8 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
- 5 generations backK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
- 4 generations backK040655 Swift Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004
- 3 generations backK072546 Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007
- 2 generations backK080646 C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 2008 · Recalled
- 1 generation backK151553 Anterior Cervical Plate SystemOsteomed Implantes, Ltda · 2016
- This deviceK161524 Tangis Anterior Cervical PlateNvision Biomedical Technologies, LLC · 2016
- Descendant · cites it directly · 4 of its ownK210424 Quantum Anterior Cervical PlateNvision Biomedical Technologies, Inc. · 2021
- Descendant · 2 generations on · 3 of its ownK252611 aprevo® cervical plating systemCarlsmed, Inc. · 2025
- Descendant · 3 generations on · 1 of its ownK260570 corra™ cervical plating systemCarlsmed, Inc. · 2026
- Descendant · cites it directly · 1 of its ownK202657 Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc. · 2020
- Descendant · 4 generations on · 0 of its ownK262149 corra® cervical plating systemCarlsmed, Inc. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K210424Quantum Anterior Cervical PlateNvision Biomedical Technologies, Inc. · 2021 · cites it directly4descendants
- K252611aprevo® cervical plating systemCarlsmed, Inc. · 2025 · 2 generations on3descendants
- K260570corra™ cervical plating systemCarlsmed, Inc. · 2026 · 3 generations on1descendant
- K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc. · 2020 · cites it directly1descendant
- K262149corra® cervical plating systemCarlsmed, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K953730 | Codman Anterior Cervical Plate System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −5 | K013877 | Codman Slim-Loc System | Codman & Shurtleff, Inc. | 2001 | — |
| −4 | K040655 | Swift Anterior Cervical Plate System | Depuy Spine, Inc. | 2004 | — |
| −3 | K072546 | Swift Plus Anterior Cervical Plate System | Depuy Spine, Inc. | 2007 | — |
| −2 | K080646 | C-Tek Maxan Anterior Cervical Plate System | Biomet Spine | 2008 | 2 |
| −1 | K151553 | Anterior Cervical Plate System | Osteomed Implantes, Ltda | 2016 | — |
| 0 (this device) | K161524 | Tangis Anterior Cervical Plate | Nvision Biomedical Technologies, LLC | 2016 | — |
| +1 | K210424 | Quantum Anterior Cervical Plate | Nvision Biomedical Technologies, Inc. | 2021 | — |
| +2 | K252611 | aprevo® cervical plating system | Carlsmed, Inc. | 2025 | — |
| +3 | K260570 | corra™ cervical plating system | Carlsmed, Inc. | 2026 | — |
| +1 | K202657 | Javelin Tailor's Bunion Fixation System | Nvision Biomedical Technologies, Inc. | 2020 | — |
| +4 | K262149 | corra® cervical plating system | Carlsmed, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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? (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 |
|---|---|---|---|
| * | K151553 | Anterior Cervical Plate SystemSummary page 5…me / Manufacturer Primary Number Predicate K151553 Anterior Cervical Plate System / Osteomed Implantes, LTDA K031276 ACLP System / Synthes Spine K… | 2016 |
| * | K031276 | Synthes Anterior Cervical Locking Plate (Aclp) SystemSummary page 5…Predicate K151553 Anterior Cervical Plate System / Osteomed Implantes, LTDA K031276 ACLP System / Synthes Spine K022965 Blackstone™ “Classic” Anterior Cervical Plate / Blackstone Medical, Inc. SUMMARY OF NON… | 2003 |
| * | K022965 | Blackstone Classic Anterior Cervical PlateSummary page 5…Predicate K151553 Anterior Cervical Plate System / Osteomed Implantes, LTDA K031276 ACLP System / Synthes Spine K022965 Blackstone™ “Classic” Anterior Cervical Plate / Blackstone Medical, Inc. SUMMARY OF NON-CLINICAL TESTING No FDA performance… | 2003 |
What descends from it? (8)
3 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 21 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
- 4 of the 33 ancestors have a recall of any class.
- Of its descendants, K210424 (Nvision Biomedical Technologies, Inc., 2021) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K151553.
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. 2016, 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 Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc…
Read the full statement (111 words)
The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion 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. fractures or dislocations),
• tumors,
• deformity (defined as kyphosis, lordosis, or scoliosis),
• pseudarthrosis,
• failed previous fusion,
• spinal stenosis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161524 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161524: Tangis Anterior Cervical Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161524
Report an extraction error
Are you the manufacturer?
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