510(k) · Cleared
ClearedOcata Anterior Cervical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kalitec Direct, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on May 9, 2017 as substantially equivalent to K010466 (Theken Surgical,Llc, 2001) and 4 other predicates after a 95-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it.
- Decided
- May 9, 2017
- Review
- 95 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K926453 (1993). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
- 2 generations backK970048 Synthes (Usa)Titanium Locking Plate System (Tilps)Synthes (Usa) · 1997
- 1 generation backK010466 Tether AcfsTheken Surgical,Llc · 2001
- This deviceK170342 Ocata Anterior Cervical SystemKalitec Direct, LLC · 2017
- Descendant · cites it directly · 0 of its ownK172086 Matira™ Anterior Cervical SystemKalitec Direct, LLC · 2017
Most influential descendants
Showing 1 of 1 · See all- K172086Matira™ Anterior Cervical SystemKalitec Direct, LLC · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K926453 | Synthes (U.S.a.) Anterior Cervical Vertebrae Plate | Synthes (Usa) | 1993 | — |
| −2 | K970048 | Synthes (Usa)Titanium Locking Plate System (Tilps) | Synthes (Usa) | 1997 | — |
| −1 | K010466 | Tether Acfs | Theken Surgical,Llc | 2001 | — |
| 0 (this device) | K170342 | Ocata Anterior Cervical System | Kalitec Direct, LLC | 2017 | — |
| +1 | K172086 | Matira™ Anterior Cervical System | Kalitec Direct, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K010466 | Tether AcfsSummary page 4…KWQ CFR Section 21 CFR section 888.3060 Device Panel Orthopedic Primary Predicate Theken Surgical TetherTM ACFS – K010466 Device Integra SonomaTM Cervical Plate System - K032368 Additional Predicate… | 2001 |
| * | K032368 | Sonoma Anterior Cervical Plate SystemSummary page 4…rthopedic Primary Predicate Theken Surgical TetherTM ACFS – K010466 Device Integra SonomaTM Cervical Plate System - K032368 Additional Predicate Stryker ReflexTM Anterior Cervical Plate System – K062310 and K040261 Devices… | 2003 |
| * | K062310 | Reflex Hybrid Acp SystemSummary page 4…Integra SonomaTM Cervical Plate System - K032368 Additional Predicate Stryker ReflexTM Anterior Cervical Plate System – K062310 and K040261 Devices Synthes CLSP Cervical Plate – K000536 The Ocata Anterio… | 2006 |
| * | K040261 | Reflex Hybrid Anterior Cervical Plate SystemSummary page 4…Integra SonomaTM Cervical Plate System - K032368 Additional Predicate Stryker ReflexTM Anterior Cervical Plate System – K062310 and K040261 Devices Synthes CLSP Cervical Plate – K000536 The Ocata Anterior Cervical S… | 2004 |
| * | K000536 | Synthes Anterior CSLP SystemSummary page 4…Predicate Stryker ReflexTM Anterior Cervical Plate System – K062310 and K040261 Devices Synthes CLSP Cervical Plate – K000536 The Ocata Anterior Cervical System components are temporary implants that are… | 2000 |
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 |
|---|---|---|---|
| K172086 | Matira™ Anterior Cervical System | 2017 | 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 3 companies; a new generation was cleared every 3.8 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K172086 (Kalitec Direct, LLC, 2017) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K010466.
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. 2017, 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 Ocata™ Anterior Cervical System is intended for anterior interbody screw fixation of the cervical spine from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine as an adjunct to fusion for 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), trauma (including fractures and dislocations)…
Read the full statement (119 words)
The Ocata™ Anterior Cervical System is intended for anterior interbody screw fixation of the cervical spine from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine as an adjunct to fusion for 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), trauma (including fractures and dislocations), tumors, spondylolisthesis, deformity (defined as kyphosis, lordosis, or scoliosis), spinal stenosis, pseudarthrosis, and/or failed previous fusions. This device system is intended for anterior cervical intervertebral body fusions only.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
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/K170342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170342: Ocata Anterior Cervical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170342
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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