510(k) · Cleared

Cleared

Discovery Facet Screw Fixation System

K012773510(k) TraditionalCleared Nov 16, 200188-day reviewClass U

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

Depuyacromed · MRW System, Facet Screw Spinal Device

Cleared on Nov 16, 2001 as substantially equivalent to K003928 (Medtronic Sofamor Danek, Inc., 2001) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 2000. 158 later devices descend from it.

Decided: Nov 16, 2001
Review: 88 days
Class: Class U
Product code: MRW
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K994308 (2000). 2 ancestors in all. 158 later devices descend from it, 14 citing it directly.

By dateBy generation

Root · 1 generation backK994308 Nuvasive Townley Facet ScrewNuvasive, Inc. · 2000
This deviceK012773 Discovery Facet Screw Fixation SystemDepuyacromed · 2001
Descendant · cites it directly · 153 of its ownK071420 Chameleon Fixation SystemSpinefrontier, Inc. · 2008 · Recalled
Descendant · cites it directly · 130 of its ownK131417 Facet FixxNexxt Spine, LLC · 2013
Descendant · 2 generations on · 106 of its ownK141376 Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx…Nexxt Spine, LLC · 2014
Descendant · 3 generations on · 100 of its ownK181435 ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018
Descendant · 4 generations on · 99 of its ownK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019

Showing 5 of 158 descendants. See all descendants

Descendants cleared per year

2006high 28 (2025) · low 0 (2007)2026

Most influential descendants

Showing 5 of 158 · See all

K071420Chameleon Fixation SystemSpinefrontier, Inc. · 2008 · cites it directly153descendants
K131417Facet FixxNexxt Spine, LLC · 2013 · cites it directly130descendants
K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC · 2014 · 2 generations on106descendants
K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018 · 3 generations on100descendants
K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019 · 4 generations on99descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K994308	Nuvasive Townley Facet Screw	Nuvasive, Inc.	2000	—
0 (this device)	K012773	Discovery Facet Screw Fixation System	Depuyacromed	2001	—
+1	K071420	Chameleon Fixation System	Spinefrontier, Inc.	2008	1
+1	K131417	Facet Fixx	Nexxt Spine, LLC	2013	—
+2	K141376	Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure…	Nexxt Spine, LLC	2014	—
+3	K181435	ATEC Cervical Spacer System	Alphatec Spine, Inc.	2018	—
+4	K183705	IdentiTi Porous Ti Interbody System	Alphatec Spine, Inc.	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	1	0
2009	2	0
2010	4	0
2011	3	0
2012	3	0
2013	4	0
2014	1	0
2015	2	0
2016	3	0
2017	1	0
2018	3	0
2019	6	0
2020	9	0
2021	6	0
2022	16	0
2023	18	0
2024	24	0
2025	28	0
2026	23	0

FIG. 1 — Lineage of K012773, 2000–2026Source: 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 MRW? 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 MRW device

#1 K230840 PMT Facet Fixation System, Lumbar (PMT FFS-LX)score 26.0 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) 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	Applicant	Decided	Recalls
*	K003928	Townley Transfacetpedicular Screw Fixation System Summary page 1 …ren F. Jurczak August 17, 2001 System, Facet Screw Spinal Device DISCOVERY Facet Screw Preamendment Townley Bone Graft Screw Townley Transfacetpedicular Screw System (K003928) Townley Transfacet/Intrapedicular Screw (K984308) The Discovery Facet Screw Fixation System is intended to stabilize the spine…	Medtronic Sofamor Danek, Inc.	2001	—
*	K994308	Nuvasive Townley Facet Screw Our OCR of the scanned summary read K984308, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Townley Transfacet/Intrapedicular Screw”.	Nuvasive, Inc.	2000	—
*	—	Preamendment Townley Bone Graft Screw Named without a submission number			—

Also cleared against K003928: 4 other devices →

What descends from it? (158)

See all 158

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

Number	Device	Applicant	Decided	Descendants
K071420	Chameleon Fixation System	Spinefrontier, Inc.	2008	153
K131417	Facet Fixx	Nexxt Spine, LLC	2013	130
K100154	Fixcet Spinal Facet Screw System	X-Spine Systems, Inc.	2010	35
K092568	Spartan S3 Facet System	Amendia, Inc.	2009	29
K102438	Primalok Facet Fixation System	Osteomed LP	2010	4
K061041	US Spine Facet Fixation System	Us Spine	2006	3
K101284	Facet Screw System	Nuvasive, Inc.	2010	2
K123497	Facet Screw System	Facet-Link, Inc.	2013	1
K101762	Viper F2 Facet Fixation System	Depuy Spine, Inc.	2010	1
K232605	Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…	Lesspine Innovations	2023	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?

None of the 2 ancestors has a recall.
Of its descendants, K071420 (Spinefrontier, Inc., 2008) has gone furthest, with 153 descendants of its own.
4 other devices also cite its predicate K003928.

How does its category compare?

All MRW devices

MRW System, Facet Screw Spinal Device: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MRW

7in 2025

2007high 7 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MRW

97in 2025

2007high 252 (2022) · low 50 (2024)2026

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

Recalls per year · MRW

3in 2011

2007high 3 (2011) · low 0 (2007)2026

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

Adverse event reports per year · MRW

3in 2025

2007high 62 (2011) · low 0 (2008)2025

MAUDE reports naming product code MRW, 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	1
2008	3	88	0	0
2009	6	89	0	2
2010	6	108	0	7
2011	3	122	3	62
2012	4	119	0	6
2013	7	110	0	4
2014	0	—	0	1
2015	2	—	0	2
2016	2	—	0	1
2017	1	—	0	4
2018	2	—	0	4
2019	3	90	0	0
2020	0	—	0	0
2021	0	—	0	1
2022	3	252	0	0
2023	3	190	0	1
2024	7	50	0	2
2025	7	97	0	3
2026	5	169	0	—

What is it indicated for?

The Discovery Facet Screw Fixation System is intended to stabilize the spine as an aid to fusion by two different fixation methods: Transfacet fixation - The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the inferior pedicle. Translaminar-facet fixation - The screws are inserted bilaterally through the lateral aspect of the spinous process, through the lamina, through the superior side of the…

Read the full statement (180 words)

The Discovery Facet Screw Fixation System is intended to stabilize the spine as an aid to

fusion by two different fixation methods:

Transfacet fixation - The screws are inserted bilaterally through the superior side of

the facet, across the facet joint and into the inferior pedicle.

Translaminar-facet fixation - The screws are inserted bilaterally through the lateral

aspect of the spinous process, through the lamina, through the superior side of the

facet across the facet joint and into the inferior pedicle.

For both methods, this system is indicated for the posterior surgical treatment of any or

all of the following at the L1 to S1 (inclusive) spinal levels: 1) Trauma, including spinal

fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis

or failed previous fusions which are symptomatic or which may cause secondary

instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc

disease (ddd) as defined by neck and/or back pain of discogenic origin as confirmed by

patient history with degeneration of the disc as confirmed by radiographic studies and/or

(b) degenerative disease of the facets with instability

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/K012773 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012773: Discovery Facet Screw Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012773

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026