510(k) Report

510(k) · Cleared

Cleared

S 100 Pedicle Screw System

K101682510(k) TraditionalCleared Dec 7, 2010175-day reviewClass II21 CFR 888.3070

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

Renovis Surgical Technologies, LLC · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Dec 7, 2010 as substantially equivalent to K042673 (Alphatec/Nexmed, 2004) and 4 other predicates after a 175-day review. Its family tree reaches back 1 generation to 1988. 8 later devices descend from it.

Decided
Dec 7, 2010
Review
175 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K884263 (1988). 5 ancestors in all. 8 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2004: 1 other ancestor2000: 2 other ancestors2017: 3 descendants cleared2020: 1 descendant cleared2023: 2 descendants cleared2025: 2 descendants clearedK884263 · Rogozinski Spinal System · Richards Medical Co., Inc. · 19881990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 2 descendants K884263 · Rogozinski Spinal System · Richards Medical Co., Inc. · 19880+5
  1. Root · 1 generation backK884263 Rogozinski Spinal SystemRichards Medical Co., Inc. · 1988
  2. This deviceK101682 S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC · 2010
  3. Descendant · cites it directly · 6 of its ownK162764 Jazz Frame SystemImplanet, S.A. · 2017
  4. Descendant · 2 generations on · 5 of its ownK170730 JAZZ System, including JAZZ BandImplanet, S.A. · 2017
  5. Descendant · 3 generations on · 3 of its ownK222097 OLYMPIC Deformity Band SystemAstura Medical · 2023
  6. Descendant · 4 generations on · 2 of its ownK231694 MASADA Modular Spinal Fixation SystemAstura Medical · 2023
  7. Descendant · 5 generations on · 0 of its ownK252346 OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal…Astura Medical · 2025

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2017: 32020: 12023: 22025: 2
2017high 3 (2017) · low 0 (2018)2026

Most influential descendants

Showing 5 of 8 · See all
  • K162764Jazz Frame SystemImplanet, S.A. · 2017 · cites it directly6descendants
  • K170730JAZZ System, including JAZZ BandImplanet, S.A. · 2017 · 2 generations on5descendants
  • K222097OLYMPIC Deformity Band SystemAstura Medical · 2023 · 3 generations on3descendants
  • K231694MASADA Modular Spinal Fixation SystemAstura Medical · 2023 · 4 generations on2descendants
  • K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical · 2025 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K884263Rogozinski Spinal SystemRichards Medical Co., Inc.1988—
0 (this device)K101682S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC2010—
+1K162764Jazz Frame SystemImplanet, S.A.2017—
+2K170730JAZZ System, including JAZZ BandImplanet, S.A.2017—
+3K222097OLYMPIC Deformity Band SystemAstura Medical2023—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical2023—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200020
200410
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201730
202010
202320
202520
FIG. 1 — Lineage of K101682, 1988–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 MNI? 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? (5)

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
*K042673Zodiac Polyaxial Spinal Fixation System
Summary page 1
…70 Class 11 3. Predicate or legally marketed devices which are substantially equivalent: ZODIAC'"M Polyaxial Spinal Fixation - K042673 (Alphatec Spine Co) Sequioa - K082032 (Abbott Spine) Moss Miami - K000536 (DePuy Synergy VLS - K000236 (DePu…
Alphatec/Nexmed20043
*K082032Sequoia Spinal System (Model 3306), Speedlink Transverse Connector (Models 3308, 3309…
Summary page 1
…1 3. Predicate or legally marketed devices which are substantially equivalent: ZODIAC'"M Polyaxial Spinal Fixation - K042673 (Alphatec Spine Co) Sequioa - K082032 (Abbott Spine) Moss Miami - K000536 (DePuy Synergy VLS - K000236 (DePuy) Rogozinski K884263 - (Smith & Nephe…
Abbott Spine, Inc.20081
*K000536Synthes Anterior CSLP System
Summary page 1
…which are substantially equivalent: ZODIAC'"M Polyaxial Spinal Fixation - K042673 (Alphatec Spine Co) Sequioa - K082032 (Abbott Spine) Moss Miami - K000536 (DePuy Synergy VLS - K000236 (DePuy) Rogozinski K884263 - (Smith & Nephew) 4. Description of the device:…
Synthes Spine20001
*K000236Synergy VLS Cap Nut Models 2206, 6102
Summary page 1
…ZODIAC'"M Polyaxial Spinal Fixation - K042673 (Alphatec Spine Co) Sequioa - K082032 (Abbott Spine) Moss Miami - K000536 (DePuy Synergy VLS - K000236 (DePuy) Rogozinski K884263 - (Smith & Nephew) 4. Description of the device: As a posterior pedlicle screw syste…
Interpore Cross Intl.2000—
*K884263Rogozinski Spinal System
Summary page 1
…Fixation - K042673 (Alphatec Spine Co) Sequioa - K082032 (Abbott Spine) Moss Miami - K000536 (DePuy Synergy VLS - K000236 (DePuy) Rogozinski K884263 - (Smith & Nephew) 4. Description of the device: As a posterior pedlicle screw system designed for temporary stabiliza…
Richards Medical Co., Inc.1988—

Also cleared against K042673: 12 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K162764Jazz Frame SystemImplanet, S.A.20176
K201568Calvary Spine Pedicle Screw SystemCalvary Spine, LLC20200

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?

  • 3 of the 5 ancestors have a recall of any class.
  • Of its descendants, K162764 (Implanet, S.A., 2017) has gone furthest, with 6 descendants of its own.
  • 12 other devices also cite its predicate K042673.

How does its category compare?

All MNI devices

MNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · MNI

1in 2017

2007: 202008: 232009: 182010: 162011: 172012: 192013: 142014: 62015: 122016: 72017: 1
2007high 23 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNI

168in 2016

2007: 82 days median2008: 64 days median2009: 86 days median2010: 74 days median2011: 111 days median2012: 75 days median2013: 77 days median2014: 104 days median2015: 54 days median2016: 168 days median
2007high 168 (2016) · low 54 (2015)2026

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

Recalls per year · MNI

1in 2018

2007: 262008: 82009: 32010: 12012: 12013: 42015: 12018: 1
2007high 26 (2007) · low 0 (2011)2026

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

Adverse event reports per year · MNI

80in 2025

2007: 832008: 1082009: 1382010: 1262011: 1462012: 2002013: 8242014: 3012015: 2602016: 1172017: 2472018: 1342019: 1882020: 1152021: 2702022: 2142023: 1222024: 1142025: 80
2007high 824 (2013) · low 80 (2025)2025

MAUDE reports naming product code MNI, 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
200720822683
200823648108
200918863138
201016741126
2011171110146
201219751200
201314774824
201461040301
201512541260
201671680117
20171—0247
20180—1134
20190—0188
20200—0115
20210—0270
20220—0214
20230—0122
20240—0114
20250—080
20260—0—

What is it indicated for?

The Renovis S 100 Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment…

Read the full statement (137 words)

The Renovis S 100 Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.

When used as a pedicle screw system, the Renovis S 100 Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the LS-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L_3to sacrum) with removal of the implants after the attainment of a solid fusion.

Indications for use as stated in the FDA summary.

Also cleared against K042673

12 other devices cite the same predicate.

  • K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC · 2014
  • K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc. · 20131 recall
  • K111940S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC · 2012
  • K113755Savannah Technologies Spinal SystemSavannah Technologies, LLC · 2012
  • K110321Tiger Spine SystemCorelink, LLC · 2011
  • K100685Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2010

More from Renovis Surgical Technologies, LLC

9 FDA decisions under this applicant name. See the company

  • K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC · 2014
  • K131354Renovis Bipolar Hip SystemRenovis Surgical Technologies, LLC · 2013
  • K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC · 2013
  • K120038A200 Knee SystemRenovis Surgical Technologies, LLC · 2013
  • K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC · 2012

Recent decisions in MNI

The MNI category page

  • K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017
  • K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 2016
  • K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc. · 2016
  • K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A. · 2016
  • K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. · 2016

https://510kreport.com/device/K101682 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101682: S 100 Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101682

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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