510(k) Report

510(k) · Cleared

Cleared

J.B.S. Implantable Spinal Fixation Device

K935113510(k) TraditionalCleared Oct 19, 1994359-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

J.B.S., S.A. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Oct 19, 1994 after a 359-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 253 later devices descend from it.

Decided
Oct 19, 1994
Review
359 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
0

253 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1998: 2 descendants cleared2000: 1 descendant cleared1999: 2 descendants cleared2011: 4 descendants cleared2012: 7 descendants cleared2005: 1 descendant cleared2004: 5 descendants cleared2002: 1 descendant cleared2007: 2 descendants cleared2006: 2 descendants cleared2001: 1 descendant cleared2016: 14 descendants cleared2009: 1 descendant cleared2008: 1 descendant cleared2014: 6 descendants cleared2015: 9 descendants cleared2021: 13 descendants cleared2013: 7 descendants cleared2017: 16 descendants cleared2010: 2 descendants cleared2019: 14 descendants cleared2020: 18 descendants cleared2018: 13 descendants cleared2024: 27 descendants cleared2023: 23 descendants cleared2025: 26 descendants cleared2022: 17 descendants cleared2026: 18 descendants cleared1990200020102020
  1. This deviceK935113 J.B.S. Implantable Spinal Fixation DeviceJ.B.S., S.A. · 1994
  2. Descendant · cites it directly · 251 of its ownK982914 Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc. · 1998
  3. Descendant · cites it directly · 251 of its ownK980484 Aesculap Spine System EvolutionAesculap, Inc. · 1998
  4. Descendant · 2 generations on · 250 of its ownK990118 Isobar Spinal SystemScien'Tx USA, Inc. · 1999
  5. Descendant · 3 generations on · 131 of its ownK061162 Bar Pedicle Screw Spinal Fixation System, Model 2020Applied Spine Technologies, Inc. · 2006
  6. Descendant · 4 generations on · 130 of its ownK092624 Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2009 · Recalled

Showing 5 of 253 descendants. See all descendants

Descendants cleared per year

1998: 21999: 22000: 12001: 12002: 12004: 52005: 12006: 22007: 22008: 12009: 12010: 22011: 42012: 72013: 72014: 62015: 92016: 142017: 162018: 132019: 142020: 182021: 132022: 172023: 232024: 272025: 262026: 18
1998high 27 (2024) · low 0 (2003)2026

Most influential descendants

Showing 5 of 253 · See all
  • K982914Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc. · 1998 · cites it directly251descendants
  • K980484Aesculap Spine System EvolutionAesculap, Inc. · 1998 · cites it directly251descendants
  • K990118Isobar Spinal SystemScien'Tx USA, Inc. · 1999 · 2 generations on250descendants
  • K061162Bar Pedicle Screw Spinal Fixation System, Model 2020Applied Spine Technologies, Inc. · 2006 · 3 generations on131descendants
  • K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2009 · 4 generations on130descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K935113J.B.S. Implantable Spinal Fixation DeviceJ.B.S., S.A.1994—
+1K982914Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc.1998—
+1K980484Aesculap Spine System EvolutionAesculap, Inc.1998—
+2K990118Isobar Spinal SystemScien'Tx USA, Inc.1999—
+3K061162Bar Pedicle Screw Spinal Fixation System, Model 2020Applied Spine Technologies, Inc.2006—
+4K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc.20091

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
199920
200010
200110
200210
200450
200510
200620
200720
200810
200910
201020
201140
201270
201370
201460
201590
2016140
2017160
2018130
2019140
2020180
2021130
2022170
2023230
2024270
2025260
2026180
FIG. 1 — Lineage of K935113, 1994–2026Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (253)

See all 253

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

NumberDeviceApplicantDecidedDescendants
K982914Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc.1998251
K980484Aesculap Spine System EvolutionAesculap, Inc.1998251

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, K982914 (Aesculap, Inc., 1998) has gone furthest, with 251 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—

More from J.B.S., S.A.

10 FDA decisions under this applicant name. See the company

  • K962757J.B.S. Spine System with Pedicle Screws - Additional Components - Screws, Linking Plates, Hooks and Rod ClampJ.B.S., S.A. · 1996
  • K955864J.B. S. C1-C2 ClampJ.B.S., S.A. · 1996
  • K953881Spine System Sacral PlateJ.B.S., S.A. · 1996
  • K953599Clamp AssemblyJ.B.S., S.A. · 1995
  • K952298Spinal Pedicle Screw, Fixation, ApplianceJ.B.S., S.A. · 1995

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/K935113 · printed Nov 5, 2026

Cite this page

510(k) Report. “K935113: J.B.S. Implantable Spinal Fixation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K935113

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026