510(k) Report

510(k) · Cleared

Cleared

Aladyn Rigid Spine Plate

K040747510(k) SpecialCleared Jun 17, 200486-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

Scient'X · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Jun 17, 2004 as substantially equivalent to K990721 (Scien'Tx USA, Inc., 1999) and 1 other predicate after an 86-day review. Its family tree reaches back 5 generations to 1990.

Decided
Jun 17, 2004
Review
86 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K901587 (1990). 28 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 2 other ancestors1998: 2 other ancestors1996: 4 other ancestors1997: 2 other ancestors1995: 3 other ancestors1994: 2 other ancestors1993: 2 other ancestors1992: 5 other ancestors1990: 1 other ancestorK901587 · TSRH Sacral L-Connector · Danek Medical, Inc. · 1990K950099 · Synergy (TM) TI Posterior Spinal System · Buckman Co., Inc. · 1997K973836 · Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy Anterior Spinal System · Cross Medical Products, Inc. · 1998K980484 · Aesculap Spine System Evolution · Aesculap, Inc. · 1998K990118 · Isobar Spinal System · Scien'Tx USA, Inc. · 19991990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors3 generations back: 17 other ancestors4 generations back: 2 other ancestors K990118 · Isobar Spinal System · Scien'Tx USA, Inc. · 1999K980484 · Aesculap Spine System Evolution · Aesculap, Inc. · 1998K973836 · Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy Anterior Spinal System · Cross Medical Products, Inc. · 1998K950099 · Synergy (TM) TI Posterior Spinal System · Buckman Co., Inc. · 1997K901587 · TSRH Sacral L-Connector · Danek Medical, Inc. · 1990−50
  1. Root · 5 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
  2. 4 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
  3. 3 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
  4. 2 generations backK980484 Aesculap Spine System EvolutionAesculap, Inc. · 1998
  5. 1 generation backK990118 Isobar Spinal SystemScien'Tx USA, Inc. · 1999
  6. This deviceK040747 Aladyn Rigid Spine PlateScient'X · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K901587TSRH Sacral L-ConnectorDanek Medical, Inc.1990—
−4K950099Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc.1997—
−3K973836Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross…Cross Medical Products, Inc.1998—
−2K980484Aesculap Spine System EvolutionAesculap, Inc.1998—
−1K990118Isobar Spinal SystemScien'Tx USA, Inc.1999—
0 (this device)K040747Aladyn Rigid Spine PlateScient'X2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199250
199320
199420
199530
199640
199720
199820
199920
FIG. 1 — Lineage of K040747, 1990–2004Source: 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
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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
*K990721Isolock Spinal System
Summary page 1
…cation name Spondylolisthesis spinal fixation device system Pedicle screw spinal system Equivalent Device The Aladyn Rigid Spine Plate is a modification to the ISOLOCK (K990721) and ISOBAR (K9901 18) Pedicle Screw Systems. Device Description The Aladyn Rigid Spine Plate consists of plates, pedicle screws…
Scien'Tx USA, Inc.1999—
*K990118Isobar Spinal System
Summary page 1
…isthesis spinal fixation device system Pedicle screw spinal system Equivalent Device The Aladyn Rigid Spine Plate is a modification to the ISOLOCK (K990721) and ISOBAR (K9901 18) Pedicle Screw Systems. Device Description The Aladyn Rigid Spine Plate consists of plates, pedicle screws and a polyaxial nut.…
Scien'Tx USA, Inc.1999—

Also cleared against K990721: 1 other device →

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 14 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
  • None of the 28 ancestors has a recall.
  • 1 other device also cites its predicate K990721.

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 Aladyn Rigid Spine Plate 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 the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed…

Read the full statement (125 words)

The Aladyn Rigid Spine Plate 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 the 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 Aladyn Rigid Spine Plate is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumnbar and sacral spine (L3 to 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 K990721

1 other device cites the same predicate.

  • K001080Spine System EvolutionAesculap, Inc. · 2000

More from Scient'X

12 FDA decisions under this applicant name. See the company

  • K071261Isobar Semi-Rigid Dual DampenerScient'X · 2008
  • K062912Scient'x Spinal SystemScient'X · 2007
  • K052763Stella Cervical PlateScient'X · 2005
  • K052367Scient'x Cement RestrictorScient'X · 2005
  • K050348CO Vertebral Body ReplacementScient'X · 2005

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/K040747 · printed Nov 5, 2026

Cite this page

510(k) Report. “K040747: Aladyn Rigid Spine Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040747

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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