510(k) Report

510(k) · Cleared

Cleared

Isolock Spinal System

K990721510(k) TraditionalCleared May 27, 199983-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

Scien'Tx USA, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on May 27, 1999 as substantially equivalent to K951846 (Alphatec Mfg., Inc., 1996) and 1 other predicate after an 83-day review. Its family tree reaches back 1 generation to 1996. 64 later devices descend from it.

Decided
May 27, 1999
Review
83 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K951846 (1996). 2 ancestors in all. 64 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor2000: 1 descendant cleared2004: 1 descendant cleared2011: 1 descendant cleared2012: 2 descendants cleared2013: 1 descendant cleared2016: 3 descendants cleared2017: 6 descendants cleared2018: 3 descendants cleared2021: 3 descendants cleared2014: 1 descendant cleared2024: 11 descendants cleared2023: 8 descendants cleared2020: 6 descendants cleared2019: 4 descendants cleared2025: 6 descendants cleared2022: 1 descendant cleared2026: 6 descendants clearedK951846 · Mirage Spinal System for Severe Spondylolisthesis · Alphatec Mfg., Inc. · 19961995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 7 descendants4 generations forward: 17 descendants5 generations forward: 12 descendants6 generations forward: 9 descendants7 generations forward: 4 descendants8 generations forward: 7 descendants9 generations forward: 4 descendants K951846 · Mirage Spinal System for Severe Spondylolisthesis · Alphatec Mfg., Inc. · 19960+5
  1. Root · 1 generation backK951846 Mirage Spinal System for Severe SpondylolisthesisAlphatec Mfg., Inc. · 1996
  2. This deviceK990721 Isolock Spinal SystemScien'Tx USA, Inc. · 1999
  3. Descendant · cites it directly · 62 of its ownK001080 Spine System EvolutionAesculap, Inc. · 2000
  4. Descendant · 2 generations on · 61 of its ownK112551 S4 Spinal SystemAesculap Implant System, Inc. · 2011
  5. Descendant · 2 generations on · 51 of its ownK123352 S4 Spinal SystemAesculap Implant Systems, Inc. · 2012
  6. Descendant · 3 generations on · 44 of its ownK130291 S4 Spinal SystemAesculap Implant System, Inc. · 2013
  7. Descendant · 4 generations on · 39 of its ownK182377 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018

Showing 5 of 64 descendants. See all descendants

Descendants cleared per year

2000: 12004: 12011: 12012: 22013: 12014: 12016: 32017: 62018: 32019: 42020: 62021: 32022: 12023: 82024: 112025: 62026: 6
2000high 11 (2024) · low 0 (2001)2026

Most influential descendants

Showing 5 of 64 · See all
  • K001080Spine System EvolutionAesculap, Inc. · 2000 · cites it directly62descendants
  • K112551S4 Spinal SystemAesculap Implant System, Inc. · 2011 · 2 generations on61descendants
  • K123352S4 Spinal SystemAesculap Implant Systems, Inc. · 2012 · 2 generations on51descendants
  • K130291S4 Spinal SystemAesculap Implant System, Inc. · 2013 · 3 generations on44descendants
  • K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018 · 4 generations on39descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K951846Mirage Spinal System for Severe SpondylolisthesisAlphatec Mfg., Inc.1996—
0 (this device)K990721Isolock Spinal SystemScien'Tx USA, Inc.1999—
+1K001080Spine System EvolutionAesculap, Inc.2000—
+2K112551S4 Spinal SystemAesculap Implant System, Inc.2011—
+2K123352S4 Spinal SystemAesculap Implant Systems, Inc.2012—
+3K130291S4 Spinal SystemAesculap Implant System, Inc.2013—
+4K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200410
201110
201220
201310
201410
201630
201760
201830
201940
202060
202130
202210
202380
2024110
202560
202660
FIG. 1 — Lineage of K990721, 1996–2026Source: 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.

Planning a device in MNH? 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? (2)

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
*K951846Mirage Spinal System for Severe Spondylolisthesis
Summary page 1
…OLOCK Spinal System has similar design characteristics, i.e., material, screw size, lateral screw/rod connection, crosslinking connectors and indications, as the Mirage (K951846) and VSP (K984350) systems distributed by Alphatec Manufacturing and DePuy Motech Acromed, respectively. [P ORTRYIN === Page 2…
Alphatec Mfg., Inc.1996—
*K984350VSP System
Summary page 1
…m has similar design characteristics, i.e., material, screw size, lateral screw/rod connection, crosslinking connectors and indications, as the Mirage (K951846) and VSP (K984350) systems distributed by Alphatec Manufacturing and DePuy Motech Acromed, respectively. [P ORTRYIN DEPARTMENT OF…
Depuy Motech Acromed1999—

Also cleared against K951846: 5 other devices →

What descends from it? (64)

See all 64

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

NumberDeviceApplicantDecidedDescendants
K001080Spine System EvolutionAesculap, Inc.200062
K040747Aladyn Rigid Spine PlateScient'X20040

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, K001080 (Aesculap, Inc., 2000) has gone furthest, with 62 descendants of its own.
  • 5 other devices also cite its predicate K951846.

How does its category compare?

All MNH devices

MNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNH

8in 2016

2007: 52008: 132009: 132010: 102011: 172012: 72013: 102014: 122015: 102016: 8
2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007: 123 days median2008: 65 days median2009: 151 days median2010: 106 days median2011: 171 days median2012: 93 days median2013: 124 days median2014: 140 days median2015: 99 days median2016: 93 days median
2007high 171 (2011) · low 65 (2008)2026

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

Recalls per year · MNH

1in 2016

2009: 72012: 12013: 12016: 1
2007high 7 (2009) · low 0 (2007)2026

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

Adverse event reports per year · MNH

89in 2025

2007: 182008: 302009: 452010: 592011: 1072012: 4332013: 4642014: 2862015: 1522016: 2162017: 1742018: 1292019: 4032020: 4322021: 5312022: 2652023: 1212024: 3022025: 89
2007high 531 (2021) · low 18 (2007)2025

MAUDE reports naming product code MNH, 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
20075123018
20081365030
200913151745
201010106059
2011171710107
20127931433
2013101241464
2014121400286
201510990152
20168931216
20170—0174
20180—0129
20190—0403
20200—0432
20210—0531
20220—0265
20230—0121
20240—0302
20250—089
20260—0—

What is it indicated for?

The ISOLOCK Spinal System is a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous…

Read the full statement (123 words)

The ISOLOCK Spinal System is a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system, the ISOLOCK Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

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

Also cleared against K951846

5 other devices cite the same predicate.

  • K023299Alpha Mirage Top Tightening Spinal SystemAlphatec Mfg., Inc. · 2002
  • K001080Spine System EvolutionAesculap, Inc. · 2000
  • K990118Isobar Spinal SystemScien'Tx USA, Inc. · 1999
  • K982914Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc. · 1998
  • K980484Aesculap Spine System EvolutionAesculap, Inc. · 1998

More from Scien'Tx USA, Inc.

8 FDA decisions under this applicant name. See the company

  • K020245Modification to Isobar Spinal SystemScien'Tx USA, Inc. · 2002
  • K013447Isobar Spinal SystemScien'Tx USA, Inc. · 2002
  • K013439Anterior Cervical Plate SystemScien'Tx USA, Inc. · 2002
  • K013440Isobar Spinal SystemScien'Tx USA, Inc. · 2001
  • K013444Isobar Spinal SystemScien'Tx USA, Inc. · 2001

Recent decisions in MNH

The MNH category page

  • K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016
  • K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2016
  • K162143FixxSure® X-LinkInnovasis, Inc. · 2016
  • K161151Spinal fixation systemCanwell Medical Co., Ltd. · 2016
  • K162189ANAX™ 5.5 Spinal SystemU&I Corporation · 2016

https://510kreport.com/device/K990721 · printed Nov 5, 2026

Cite this page

510(k) Report. “K990721: Isolock Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990721

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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