510(k) Report

510(k) · Cleared

Cleared

Matira™ Anterior Cervical System

K172086510(k) TraditionalCleared Sep 22, 201773-day reviewClass II21 CFR 888.3060

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Kalitec Direct, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Sep 22, 2017 as substantially equivalent to K170342 (Kalitec Direct, LLC, 2017) after a 73-day review. Its family tree reaches back 4 generations to 1993.

Decided
Sep 22, 2017
Review
73 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K926453 (1993). 11 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestor2004: 1 other ancestor2003: 1 other ancestor2000: 2 other ancestors1995: 1 other ancestor1993: 1 other ancestorK926453 · Synthes (U.S.a.) Anterior Cervical Vertebrae Plate · Synthes (Usa) · 1993K970048 · Synthes (Usa)Titanium Locking Plate System (Tilps) · Synthes (Usa) · 1997K010466 · Tether Acfs · Theken Surgical,Llc · 2001K170342 · Ocata Anterior Cervical System · Kalitec Direct, LLC · 2017199019952000200520102015
Other ancestors, by generation 2 generations back: 4 other ancestors3 generations back: 1 other ancestor4 generations back: 2 other ancestors K170342 · Ocata Anterior Cervical System · Kalitec Direct, LLC · 2017K010466 · Tether Acfs · Theken Surgical,Llc · 2001K970048 · Synthes (Usa)Titanium Locking Plate System (Tilps) · Synthes (Usa) · 1997K926453 · Synthes (U.S.a.) Anterior Cervical Vertebrae Plate · Synthes (Usa) · 19930
  1. Root · 4 generations backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
  2. 3 generations backK970048 Synthes (Usa)Titanium Locking Plate System (Tilps)Synthes (Usa) · 1997
  3. 2 generations backK010466 Tether AcfsTheken Surgical,Llc · 2001
  4. 1 generation backK170342 Ocata Anterior Cervical SystemKalitec Direct, LLC · 2017
  5. This deviceK172086 Matira™ Anterior Cervical SystemKalitec Direct, LLC · 2017
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K926453Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa)1993—
−3K970048Synthes (Usa)Titanium Locking Plate System (Tilps)Synthes (Usa)1997—
−2K010466Tether AcfsTheken Surgical,Llc2001—
−1K170342Ocata Anterior Cervical SystemKalitec Direct, LLC2017—
0 (this device)K172086Matira™ Anterior Cervical SystemKalitec Direct, LLC2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199510
200020
200310
200410
200610
FIG. 1 — Lineage of K172086, 1993–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K170342Ocata Anterior Cervical System
Summary page 4
…FR Section 21 CFR section 888.3060 Device Panel Orthopedic Primary Predicate Device Ocata Anterior Cervical System TM (K170342) Secondary Predicate Devices None The Matira Anterior Cervical System components are temp…
Kalitec Direct, LLC2017—

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 24 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
  • 3 of the 11 ancestors have a recall of any class.

How does its category compare?

All KWQ devices

KWQ 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

2007: 272008: 322009: 232010: 232011: 222012: 262013: 222014: 172015: 252016: 152017: 202018: 222019: 262020: 262021: 172022: 182023: 162024: 172025: 72026 (partial year): 10
2007high 32 (2008) · low 7 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWQ

64in 2025

2007: 101 days median2008: 70 days median2009: 90 days median2010: 104 days median2011: 95 days median2012: 90 days median2013: 88 days median2014: 124 days median2015: 102 days median2016: 121 days median2017: 67 days median2018: 95 days median2019: 81 days median2020: 55 days median2021: 59 days median2022: 85 days median2023: 59 days median2024: 64 days median2025: 64 days median2026 (partial year): 76 days median
2007high 124 (2014) · low 55 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWQ

1in 2018

2007: 22008: 332009: 352010: 22011: 52012: 72013: 62015: 22016: 92017: 82018: 1
2007high 35 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWQ

248in 2025

2007: 2882008: 3482009: 3552010: 6912011: 4152012: 5442013: 7962014: 5462015: 5622016: 5022017: 4922018: 3412019: 2982020: 4002021: 5912022: 3922023: 3202024: 4192025: 248
2007high 796 (2013) · low 248 (2025)2025

MAUDE reports naming product code KWQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007271012288
2008327033348
2009239035355
2010231042691
201122955415
201226907544
201322886796
2014171240546
2015251022562
2016151219502
201720678492
201822951341
201926810298
202026550400
202117590591
202218850392
202316590320
202417640419
20257640248
202610760—

What is it indicated for?

The Matira™ Anterior Cervical System is intended for anterior interbody screw fixation of the cervical spine from C2 to Tl. 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 Matira™ Anterior Cervical System is intended for anterior interbody screw fixation of the cervical spine from C2 to Tl. 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 as stated in the FDA summary.

More from Kalitec Direct, LLC

9 FDA decisions under this applicant name. See the company

  • K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC · 2018
  • K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC · 2017
  • K170342Ocata Anterior Cervical SystemKalitec Direct, LLC · 2017
  • K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC · 2017
  • K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC · 2014

Recent decisions in KWQ

The KWQ category page

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https://510kreport.com/device/K172086 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172086: Matira™ 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/K172086

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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