510(k) Report

510(k) · Cleared

Cleared

Sapphire Cervical Implant System

K172674510(k) SpecialCleared Nov 2, 201758-day reviewClass II21 CFR 888.3080

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

Sapphire Medical Group · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Nov 2, 2017 after a 58-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 later devices descend from it.

Decided
Nov 2, 2017
Review
58 days
Class
Class II
Product code
ODP
Recalls
None
Predicates
0

9 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2018: 1 descendant cleared2023: 3 descendants cleared2022: 2 descendants cleared2026: 2 descendants cleared2025: 1 descendant cleared201620182020202220242026
  1. This deviceK172674 Sapphire Cervical Implant SystemSapphire Medical Group · 2017
  2. Descendant · cites it directly · 8 of its ownK181115 CxHA PEEK Cervical IBF SystemInnovasis, Inc. · 2018
  3. Descendant · 2 generations on · 4 of its ownK220875 HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc. · 2022
  4. Descendant · 3 generations on · 2 of its ownK231899 HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc. · 2023
  5. Descendant · 2 generations on · 1 of its ownK222041 CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd. · 2023
  6. Descendant · 4 generations on · 0 of its ownK262025 Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF…INNO Holdings Inc. DBA Innovasis · 2026

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2018: 12022: 22023: 32025: 12026: 2
2018high 3 (2023) · low 0 (2019)2026

Most influential descendants

Showing 5 of 9 · See all
  • K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc. · 2018 · cites it directly8descendants
  • K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc. · 2022 · 2 generations on4descendants
  • K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc. · 2023 · 3 generations on2descendants
  • K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd. · 2023 · 2 generations on1descendant
  • K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis · 2026 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K172674Sapphire Cervical Implant SystemSapphire Medical Group2017—
+1K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.2018—
+2K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.2022—
+3K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.2023—
+2K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.2023—
+4K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF…INNO Holdings Inc. DBA Innovasis2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
202220
202330
202510
202620
FIG. 1 — Lineage of K172674, 2017–2026Source: 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in ODP? 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 ODP device

  1. #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (9)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188

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?

  • Of its descendants, K181115 (Innovasis, Inc., 2018) has gone furthest, with 8 descendants of its own.

How does its category compare?

All ODP devices

ODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · ODP

11in 2025

2008: 82009: 122010: 92011: 252012: 172013: 182014: 262015: 242016: 172017: 332018: 252019: 222020: 142021: 182022: 122023: 342024: 102025: 112026 (partial year): 19
2007high 34 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODP

87in 2025

2008: 89 days median2009: 127 days median2010: 151 days median2011: 113 days median2012: 93 days median2013: 187 days median2014: 118 days median2015: 180 days median2016: 112 days median2017: 104 days median2018: 133 days median2019: 92 days median2020: 89 days median2021: 121 days median2022: 92 days median2023: 165 days median2024: 76 days median2025: 87 days median2026 (partial year): 117 days median
2007high 187 (2013) · low 76 (2024)2026

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

Recalls per year · ODP

2in 2025

2009: 12011: 12013: 12020: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

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

Adverse event reports per year · ODP

57in 2025

2008: 22009: 212010: 542011: 382012: 922013: 782014: 432015: 512016: 372017: 392018: 512019: 1412020: 862021: 1612022: 502023: 362024: 552025: 57
2007high 161 (2021) · low 0 (2007)2025

MAUDE reports naming product code ODP, 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
20070—00
200888902
200912127121
20109151054
201125113138
20121793092
201318187178
201426118043
201524180051
201617112037
201733104039
201825133051
201922920141
20201489186
2021181210161
20221292050
202334165036
20241076055
20251187257
2026191170—

What is it indicated for?

The Cervical Implant is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with autogenous bone graft. The Cervical Implant is intended to be used with supplemental fixation system.

Indications for use as stated in the FDA 510(k) statement.

More from Sapphire Medical Group

4 FDA decisions under this applicant name. See the company

  • K232619MATRIX HA PEEK Cervical IBF SystemSapphire Medical Group · 2024
  • K192316Matrix HA PEEK Cervical Implant SystemSapphire Medical Group · 2019
  • K183073SMG Anterior Cervical Plate SystemSapphire Medical Group · 2019

Recent decisions in ODP

The ODP category page

  • K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc. · 2026
  • K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd. · 2026
  • K2530413d Cage CervicalFims Co., Ltd. · 2026
  • K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero®…Stryker Spine · 2026
  • K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC · 2026

https://510kreport.com/device/K172674 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172674: Sapphire Cervical Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172674

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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