510(k) Report

510(k) · Cleared

Cleared

Alpha Mirage Top Tightening Spinal System

K020356510(k) TraditionalCleared Jul 23, 2002169-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

Alphatec Mfg., Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Jul 23, 2002 as substantially equivalent to K982990 (Sofamor Danek USA,Inc., 1998) after a 169-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.

Decided
Jul 23, 2002
Review
169 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K982990 (1998). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant clearedReference device: K951846 · Mirage Spinal System for Severe Spondylolisthesis · Alphatec Mfg., Inc. · 1996Reference device: K930515 · Alpha Spinal System · Alphatec Mfg., Inc. · 1994K982990 · TSRH Spinal System · Sofamor Danek USA,Inc. · 19981995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant K982990 · TSRH Spinal System · Sofamor Danek USA,Inc. · 19980
  1. Root · 1 generation backK982990 TSRH Spinal SystemSofamor Danek USA,Inc. · 1998
  2. This deviceK020356 Alpha Mirage Top Tightening Spinal SystemAlphatec Mfg., Inc. · 2002
  3. Descendant · cites it directly · 0 of its ownK023299 Alpha Mirage Top Tightening Spinal SystemAlphatec Mfg., Inc. · 2002

Most influential descendants

Showing 1 of 1 · See all
  • K023299Alpha Mirage Top Tightening Spinal SystemAlphatec Mfg., Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K982990TSRH Spinal SystemSofamor Danek USA,Inc.1998—
0 (this device)K020356Alpha Mirage Top Tightening Spinal SystemAlphatec Mfg., Inc.2002—
+1K023299Alpha Mirage Top Tightening Spinal SystemAlphatec Mfg., Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K020356, 1998–2002Source: 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? (1)

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
*K982990TSRH Spinal System
Summary page 2
…February 2002 TradelProprietary Name Manufacturer Clearance TSRH Sofamor-Danek K982990 The new pedicle screw classification indications described in the classification Final Rule, July 17, 1998 were referenced.…
Sofamor Danek USA,Inc.1998—
†K951846Mirage Spinal System for Severe SpondylolisthesisAlphatec Mfg., Inc.1996—
†K930515Alpha Spinal SystemAlphatec Mfg., Inc.1994—

Also cleared against K982990: 7 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K023299Alpha Mirage Top Tightening Spinal SystemAlphatec Mfg., Inc.20020

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?

  • Its one ancestor has no recall.
  • Of its descendants, K023299 (Alphatec Mfg., Inc., 2002) has gone furthest, with 0 descendants of its own.
  • 7 other devices also cite its predicate K982990.

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?

It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only. 1) The Alpha Mirage@Top Tightening Spinal System, when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for: a. Patients having fractures of the thoracic and lumbar spine. b. Patients having deformity (i.e.…

Read the full statement (247 words)

It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only.

1) The Alpha Mirage@Top Tightening Spinal System, when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:

a. Patients having fractures of the thoracic and lumbar spine.

b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).

c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).

2) The Alpha Mirage@Top Tightening Spinal System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumore and failed previous fusion (pseudoarthrosis).

3) In addition, the Alpha Mirage@Top Tightening Spinal System, when used as a pedicle screw fixation system is intended for:

a. Patients receiving only autogenous bone graft.

b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.

4) The Alpha Mirage@Top Tightening Spinal System, when used as a laminar hook and bone screw system is intended for:

b. Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).

c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).

Indications for use as stated in the FDA summary.

Also cleared against K982990

7 other devices cite the same predicate.

  • K110676TSRH Spinal SystemMedtronic Sofamor Danek · 2011
  • K093058TSRH Spinal SystemMedtronic Sofamor Danek, Inc. · 2009
  • K072317Modification to:TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc. · 20074 recalls
  • K030087Spinal Concepts, Inc. Bacfix TI Spinal SystemSpinal Concepts, Inc. · 2003
  • K013447Isobar Spinal SystemScien'Tx USA, Inc. · 2002
  • K013440Isobar Spinal SystemScien'Tx USA, Inc. · 2001

More from Alphatec Mfg., Inc.

20 FDA decisions under this applicant name. See the company

  • K033090Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc. · 20041 recall
  • K023299Alpha Mirage Top Tightening Spinal SystemAlphatec Mfg., Inc. · 2002
  • K993513Deltaloc Anterior Cervical Plate SystemAlphatec Mfg., Inc. · 2000
  • K993873Alphatec External Fixation System Compression/Distraction RodAlphatec Mfg., Inc. · 2000
  • K992350Pylon Intramedullaary Nail SystemAlphatec Mfg., Inc. · 1999

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/K020356 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020356: Alpha Mirage Top Tightening Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020356

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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