510(k) Report

510(k) · Cleared

Cleared

Synthes Cervifix System

K994187510(k) SpecialCleared Dec 21, 19998-day reviewClass II21 CFR 888.3050

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

Synthes (Usa) · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Dec 21, 1999 after an 8-day review. The FDA summary names no predicate by number. 2 of the 675 devices in its family, counting itself, have a Class I recall. 674 later devices descend from it.

Decided
Dec 21, 1999
Review
8 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
0

674 later devices descend from it, 5 citing it directly. 2 of the 675 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2000: 1 descendant cleared2018: 38 descendants cleared2014: 32 descendants cleared2023: 66 descendants cleared2017: 38 descendants cleared2004: 4 descendants cleared2005: 3 descendants cleared2019: 32 descendants cleared2008: 14 descendants cleared2013: 31 descendants cleared2007: 8 descendants cleared2003: 2 descendants cleared2012: 29 descendants cleared2006: 4 descendants cleared2002: 1 descendant cleared2010: 13 descendants cleared, 1 with a Class I recall12001: 1 descendant cleared2015: 38 descendants cleared2025: 50 descendants cleared2024: 57 descendants cleared2011: 15 descendants cleared2009: 10 descendants cleared2020: 38 descendants cleared2021: 33 descendants cleared, 1 with a Class I recall12016: 29 descendants cleared2022: 38 descendants cleared2026: 49 descendants cleared1995200020052010201520202025
  1. This deviceK994187 Synthes Cervifix SystemSynthes (Usa) · 1999
  2. Descendant · cites it directly · 671 of its ownK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
  3. Descendant · 2 generations on · 660 of its ownK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
  4. Descendant · 2 generations on · 659 of its ownK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
  5. Descendant · 2 generations on · 658 of its ownK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
  6. Descendant · 2 generations on · 657 of its ownK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004

Showing 5 of 674 descendants. See all descendants

Descendants cleared per year

2000: 12001: 12002: 12003: 22004: 42005: 32006: 42007: 82008: 142009: 102010: 132011: 152012: 292013: 312014: 322015: 382016: 292017: 382018: 382019: 322020: 382021: 332022: 382023: 662024: 572025: 502026: 49
2000high 66 (2023) · low 1 (2000)2026

Class I recalls in this family

  • K093670 Modification to: Oasys System4 generations on · 2010
  • K211616 ExcelsiusHub5 generations on · 2021

Most influential descendants

Showing 5 of 674 · See all
  • K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000 · cites it directly671descendants
  • K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001 · 2 generations on660descendants
  • K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002 · 2 generations on659descendants
  • K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003 · 2 generations on658descendants
  • K041203Summit Oct Spinal SystemDepuy Spine, Inc. · 2004 · 2 generations on657descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K994187Synthes Cervifix SystemSynthes (Usa)1999—
+1K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2000—
+2K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed2001—
+2K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2002—
+2K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed2003—
+2K041203Summit Oct Spinal SystemDepuy Spine, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200110
200210
200320
200440
200530
200640
200780
2008140
2009100
2010131
2011150
2012290
2013310
2014320
2015380
2016290
2017380
2018380
2019320
2020380
2021331
2022380
2023660
2024570
2025500
2026490
FIG. 1 — Lineage of K994187, 1999–2026Source: 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 summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (674)

See all 674

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

NumberDeviceApplicantDecidedDescendants
K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2000671
K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.201427
K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184
K230614Cortium™Ulrich Medical USA20230
K171834G Surgical OCT Spinal SystemG Surgical, LLC20170

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K093670Modification to: Oasys SystemStryker Spine · 2010 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K002733 (Depuyacromed, 2000) has gone furthest, with 671 descendants of its own.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWP

9in 2015

2007: 142008: 132009: 122010: 142011: 122012: 182013: 122014: 132015: 9
2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007: 96 days median2008: 50 days median2009: 89 days median2010: 186 days median2011: 67 days median2012: 112 days median2013: 99 days median2014: 138 days median2015: 113 days median
2007high 186 (2010) · low 50 (2008)2026

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

Recalls per year · KWP

2in 2022

2007: 22008: 12009: 232010: 22011: 62012: 12013: 32015: 12016: 32018: 12019: 22022: 2
2007high 23 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWP

494in 2025

2007: 2102008: 5942009: 6822010: 4742011: 7922012: 9182013: 1,0902014: 1,0222015: 1,3482016: 1,3792017: 8642018: 6572019: 5182020: 7962021: 5252022: 3352023: 3322024: 4362025: 494
2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, 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
200714962210
200813501594
2009128923682
2010141862474
201112676792
2012181121918
2013129931,090
20141313801,022
2015911311,348
20160—31,379
20170—0864
20180—1657
20190—2518
20200—0796
20210—0525
20220—2335
20230—0332
20240—0436
20250—0494
20260—0—

What is it indicated for?

Hooks, Plate/Rods, Rods and Screws When intended to promote fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex, 3.5 mm and 4.0 mm cancellous) components of the Synthes CerviFix™ System are indicating for the following: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) spondylolisthesis spinal stenosis…

Read the full statement (222 words)

Hooks, Plate/Rods, Rods and Screws

When intended to promote fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex, 3.5 mm and 4.0 mm cancellous) components of the Synthes CerviFix™ System are indicating for the following:

DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)

spondylolisthesis

spinal stenosis

fracture/dislocation

atlantoaxial fracture with instability

occipitocervical dislocation

revision of previous cervical spine surgery

tumors

When used to treat these cervical and occipitocervical conditions, these screws are limited to occipital fixation only.

Hooks and Rods

The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Rods, Clamps, Screws and Nuts

The rods, clamps, screws and nuts are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).

The use of these screws (3.5 mm and 4.0 mm cancellous, 3.5 mm cortex, 4.0mm and 4.35 expansionhead) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.

The Synthes CerviFix™ System can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm parallel connectors from that system.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Synthes (Usa)

406 FDA decisions under this applicant name. See the company

  • K131984Synthes Synsonic Ulna NailSynthes (Usa) · 2014
  • K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 20111 recall
  • K111540Synthes 3.5MM LCP Clavicle Plate SystemSynthes (Usa) · 2011
  • K110789Synthes Sternal Zipfix SystemSynthes (Usa) · 20113 recalls
  • K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 20112 recalls

Recent decisions in KWP

The KWP category page

  • K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2015
  • K150753OASYS SystemStryker Corporation · 2015
  • K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
  • K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
  • K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 20153 recalls

https://510kreport.com/device/K994187 · printed Nov 5, 2026

Cite this page

510(k) Report. “K994187: Synthes Cervifix System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K994187

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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