510(k) · Cleared

Cleared

Orthovita Peek Spacer

K101171510(k) TraditionalCleared Jan 25, 2011274-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

Orthovita, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Jan 25, 2011 as substantially equivalent to K091531 (Choice Spine, Llp, 2009) after a 274-day review. Its family tree reaches back 1 generation to 2009. 225 later devices descend from it.

Decided: Jan 25, 2011
Review: 274 days
Class: Class II
Product code: ODP
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K091531 (2009). 225 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK091531 Choice Spine Cervical Interbody Spacer System Choice Spine Cervical…Choice Spine, Llp · 2009
This deviceK101171 Orthovita Peek SpacerOrthovita, Inc. · 2011
Descendant · cites it directly · 224 of its ownK120486 Avs as Peek SpacerStryker Spine · 2012
Descendant · 2 generations on · 161 of its ownK142251 AVS AS PEEK SpacerStryker Corporation · 2014
Descendant · 2 generations on · 145 of its ownK152532 AERO -C Cervical Cage SystemStryker Spine · 2015
Descendant · cites it directly · 129 of its ownK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
Descendant · 2 generations on · 106 of its ownK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018

Showing 5 of 225 descendants. See all descendants

Descendants cleared per year

2012high 36 (2025) · low 0 (2013)2026

Most influential descendants

Showing 5 of 225 · See all

K120486Avs as Peek SpacerStryker Spine · 2012 · cites it directly224descendants
K142251AVS AS PEEK SpacerStryker Corporation · 2014 · 2 generations on161descendants
K152532AERO -C Cervical Cage SystemStryker Spine · 2015 · 2 generations on145descendants
K171496Tritanium C Anterior Cervical CageStryker Spine · 2017 · cites it directly129descendants
K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018 · 2 generations on106descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K091531	Choice Spine Cervical Interbody Spacer System Choice Spine Cervical Interbody…	Choice Spine, Llp	2009	—
0 (this device)	K101171	Orthovita Peek Spacer	Orthovita, Inc.	2011	—
+1	K120486	Avs as Peek Spacer	Stryker Spine	2012	—
+2	K142251	AVS AS PEEK Spacer	Stryker Corporation	2014	—
+2	K152532	AERO -C Cervical Cage System	Stryker Spine	2015	—
+1	K171496	Tritanium C Anterior Cervical Cage	Stryker Spine	2017	—
+2	K180364	HD LifeSciences Cervical IBFD System	Hd Lifesciences, LLC	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2014	4	0
2015	2	0
2016	1	0
2017	5	0
2018	8	0
2019	11	0
2020	16	0
2021	18	0
2022	24	0
2023	32	0
2024	32	0
2025	36	0
2026	35	0

FIG. 1 — Lineage of K101171, 2009–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
#2 Held for the reportin the report
#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.

Type	Number	Device	Applicant	Decided	Recalls
*	K091531	Choice Spine Cervical Interbody Spacer System Choice Spine Cervical Interbody Spacer Summary page 1 …lass: Class 11 Product Code: ODP 3. Predicate Device(s) Choice Spine's Cervical Interbody Spacer and System (K09 153 1) 4. Device Description ORTHOVITA PEEK SPACER is a cervical interbody fusion device designed to be inserted within the interve…	Choice Spine, Llp	2009	—

Also cleared against K091531: 4 other devices →

What descends from it? (225)

See all 225

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K120486	Avs as Peek Spacer	Stryker Spine	2012	224
K171496	Tritanium C Anterior Cervical Cage	Stryker Spine	2017	129

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?

Its one ancestor has no recall.
Of its descendants, K120486 (Stryker Spine, 2012) has gone furthest, with 224 descendants of its own.
4 other devices also cite its predicate K091531.

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. 2011, this device’s year, is highlighted.

FDA decisions per year · ODP

11in 2025

2007high 34 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODP

87in 2025

2007high 187 (2013) · low 76 (2024)2026

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

Recalls per year · ODP

2in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	8	89	0	2
2009	12	127	1	21
2010	9	151	0	54
2011	25	113	1	38
2012	17	93	0	92
2013	18	187	1	78
2014	26	118	0	43
2015	24	180	0	51
2016	17	112	0	37
2017	33	104	0	39
2018	25	133	0	51
2019	22	92	0	141
2020	14	89	1	86
2021	18	121	0	161
2022	12	92	0	50
2023	34	165	0	36
2024	10	76	0	55
2025	11	87	2	57
2026	19	117	0	—

What is it indicated for?

ORTHOVITA PEEK SPACER is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-C7. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. ORTHOVITA PEEK SPACER should be used with a commercially available supplemental spinal fixation system. ORTHOVITA PEEK SPACER should also be packed with autograft prior to implantation. Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with ORTHOVITA PEEK SPACER.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101171 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101171: Orthovita Peek Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101171

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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