510(k) Report

510(k) · Cleared

Cleared

Renoir Posterior Cervial Fixation System

K121136510(k) TraditionalCleared Aug 9, 2012118-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

Accel Spine · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Aug 9, 2012 as substantially equivalent to K031985 (Spinal Concepts, Inc., 2003) and 5 other predicates after a 118-day review. Its family tree reaches back 12 generations to 1985.

Decided
Aug 9, 2012
Review
118 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
6

Its longest line of descent runs back 12 generations to K853033 (1985). 23 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 1 other ancestor2001: 2 other ancestors2004: 2 other ancestors2002: 1 other ancestor2000: 1 other ancestor1999: 4 other ancestorsK853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001K022190 · Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2002K030103 · Summit Oct Spinal System Minipolyaxial Screws · Depuyacromed · 2003K041203 · Summit Oct Spinal System · Depuy Spine, Inc. · 2004K050979 · S4 Spinal System · Aesculap, Inc. · 2005K060152 · Modification to S4 Spinal System · Aesculap, Inc. · 2006K103414 · Venus Cervical Spinal Fixation System · L&K BIOMED Co., Ltd. · 2011K120879 · Lexus Cervical Fixation System · L&K BIOMED Co., Ltd. · 2012198519901995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 3 other ancestors4 generations back: 4 other ancestors K120879 · Lexus Cervical Fixation System · L&K BIOMED Co., Ltd. · 2012K103414 · Venus Cervical Spinal Fixation System · L&K BIOMED Co., Ltd. · 2011K060152 · Modification to S4 Spinal System · Aesculap, Inc. · 2006K050979 · S4 Spinal System · Aesculap, Inc. · 2005K041203 · Summit Oct Spinal System · Depuy Spine, Inc. · 2004K030103 · Summit Oct Spinal System Minipolyaxial Screws · Depuyacromed · 2003K022190 · Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2002K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985−10−50
  1. Root · 12 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 8 generations between
  3. 3 generations backK060152 Modification to S4 Spinal SystemAesculap, Inc. · 2006
  4. 2 generations backK103414 Venus Cervical Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2011
  5. 1 generation backK120879 Lexus Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2012
  6. This deviceK121136 Renoir Posterior Cervial Fixation SystemAccel Spine · 2012
Show all 12 generations
  1. Root · 12 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 11 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
  3. 10 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
  4. 9 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
  5. 8 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
  6. 7 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
  7. 6 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
  8. 5 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
  9. 4 generations backK050979 S4 Spinal SystemAesculap, Inc. · 2005
  10. 3 generations backK060152 Modification to S4 Spinal SystemAesculap, Inc. · 2006
  11. 2 generations backK103414 Venus Cervical Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2011
  12. 1 generation backK120879 Lexus Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2012
  13. This deviceK121136 Renoir Posterior Cervial Fixation SystemAccel Spine · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K853033Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd.1985—
−11K965221Ransford Cervical Fixation SystemSurgicraft, Ltd.1997—
−10K982322Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa)1998—
−9K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2000—
−8K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed2001—
−7K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2002—
−6K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed2003—
−5K041203Summit Oct Spinal SystemDepuy Spine, Inc.2004—
−4K050979S4 Spinal SystemAesculap, Inc.2005—
−3K060152Modification to S4 Spinal SystemAesculap, Inc.2006—
−2K103414Venus Cervical Spinal Fixation SystemL&K BIOMED Co., Ltd.2011—
−1K120879Lexus Cervical Fixation SystemL&K BIOMED Co., Ltd.2012—
0 (this device)K121136Renoir Posterior Cervial Fixation SystemAccel Spine2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199940
200010
200120
200210
200310
200420
FIG. 1 — Lineage of K121136, 1985–2012Source: 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 KWP? 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? (6)

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
*K031985Spinal Concepts Inc. Nex-Link Spinal Fixation System
Summary page 1
…) Regulatory Class Class 11 3. Predicate or legally marketed devices which are substantially equivalent *Spinal Concept Inc./ Nex-Link spinal Fixation (K03 1985) *Aesculp Inc. / S4 Spinal Fixation (K050979, K060 152) *Medtronic Sofamor Danek USA Inc./VERTEX Reconstruction System…
Spinal Concepts, Inc.20034
*K050979S4 Spinal System
Summary page 1
…dicate or legally marketed devices which are substantially equivalent *Spinal Concept Inc./ Nex-Link spinal Fixation (K03 1985) *Aesculp Inc. / S4 Spinal Fixation (K050979, K060 152) *Medtronic Sofamor Danek USA Inc./VERTEX Reconstruction System (K003780) *L&K BIOMED Co.,Ltd. /LEXUS Cer…
Aesculap, Inc.2005—
*K060152Modification to S4 Spinal System
Summary page 1
…legally marketed devices which are substantially equivalent *Spinal Concept Inc./ Nex-Link spinal Fixation (K03 1985) *Aesculp Inc. / S4 Spinal Fixation (K050979, K060 152) *Medtronic Sofamor Danek USA Inc./VERTEX Reconstruction System (K003780) *L&K BIOMED Co.,Ltd. /LEXUS Cervical Fixa…
Aesculap, Inc.2006—
*K003780Vertex Reconstruction System
Summary page 1
…Nex-Link spinal Fixation (K03 1985) *Aesculp Inc. / S4 Spinal Fixation (K050979, K060 152) *Medtronic Sofamor Danek USA Inc./VERTEX Reconstruction System (K003780) *L&K BIOMED Co.,Ltd. /LEXUS Cervical Fixation System (K103414, K1 20879)…
Medtronic Sofamor Danek, Inc.2001—
*K103414Venus Cervical Spinal Fixation System
Summary page 1
…Fixation (K050979, K060 152) *Medtronic Sofamor Danek USA Inc./VERTEX Reconstruction System (K003780) *L&K BIOMED Co.,Ltd. /LEXUS Cervical Fixation System (K103414, K1 20879) KiISS3 Flyje2/3…
L&K BIOMED Co., Ltd.2011—
*K120879Lexus Cervical Fixation System
Cleared while this submission was under review
Summary page 1
…979, K060 152) *Medtronic Sofamor Danek USA Inc./VERTEX Reconstruction System (K003780) *L&K BIOMED Co.,Ltd. /LEXUS Cervical Fixation System (K103414, K1 20879) KiISS3 Flyje2/3 4. Description…
L&K BIOMED Co., Ltd.2012—

Also cleared against K031985: 9 other devices →

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 27 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
  • 1 of the 23 ancestors has a recall of any class.
  • 9 other devices also cite its predicate K031985.

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. 2012, this device’s year, is highlighted.

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?

The RENOIR Posterior Cervical Fixation System is indicated 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 * Failed previous fusion * Tumors The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of…

Read the full statement (131 words)

The RENOIR Posterior Cervical Fixation System is indicated 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

* Failed previous fusion

* Tumors

The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine.

Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (ClI -T3) spine.

The pedicle screws are limited to placement in TI -T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.

Indications for use as stated in the FDA summary.

Also cleared against K031985

9 other devices cite the same predicate.

  • K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical…Zimmer Spine, Inc. · 2015
  • K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I · 2014
  • K120879Lexus Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2012
  • K113346Neon SystemUlrich GmbH & Co. KG · 2012
  • K103414Venus Cervical Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2011
  • K062505Nex-Link Spinal Fixation System Offset Connectors, 2121-XX SeriesAbbott Spine, Inc. · 2006

More from Accel Spine

10 FDA decisions under this applicant name. See the company

  • K140219Picasso II Mis Spinal SystemAccel Spine · 2014
  • K131981Cezanne II Interbody Fusion SystemAccel Spine · 20134 recalls
  • K132366Spinal Intervertebral Body Fixation OrthosisAccel Spine · 2013
  • K132365Spondylolisthesis Spinal Fixation, Spinal Pedicle FixationAccel Spine · 20132 recalls
  • K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine · 2012

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/K121136 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121136: Renoir Posterior Cervial 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/K121136

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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