510(k) Report

510(k) · Cleared

Cleared

Alpha Mirage Top Tightening Spinal System

K023299510(k) TraditionalCleared Dec 11, 200269-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. · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Dec 11, 2002 as substantially equivalent to K930515 (Alphatec Mfg., Inc., 1994) and 2 other predicates after a 69-day review. Its family tree reaches back 2 generations to 1998.

Decided
Dec 11, 2002
Review
69 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K982990 (1998). 4 ancestors in all, the oldest K930515 (1994). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 1 other ancestor1994: 1 other ancestorK982990 · TSRH Spinal System · Sofamor Danek USA,Inc. · 1998K020356 · Alpha Mirage Top Tightening Spinal System · Alphatec Mfg., Inc. · 200219901992199419961998200020022004
Other ancestors, by generation 1 generation back: 2 other ancestors K020356 · Alpha Mirage Top Tightening Spinal System · Alphatec Mfg., Inc. · 2002K982990 · TSRH Spinal System · Sofamor Danek USA,Inc. · 19980
  1. Root · 2 generations backK982990 TSRH Spinal SystemSofamor Danek USA,Inc. · 1998
  2. 1 generation backK020356 Alpha Mirage Top Tightening Spinal SystemAlphatec Mfg., Inc. · 2002
  3. This deviceK023299 Alpha Mirage Top Tightening Spinal SystemAlphatec Mfg., Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K982990TSRH Spinal SystemSofamor Danek USA,Inc.1998—
−1K020356Alpha Mirage Top Tightening Spinal SystemAlphatec Mfg., Inc.2002—
0 (this device)K023299Alpha Mirage Top Tightening Spinal SystemAlphatec Mfg., Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199610
FIG. 1 — Lineage of K023299, 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 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
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What was it cleared against? (3)

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
*K930515Alpha Spinal System
Summary page 3
…ng predicate device: Trade/Proprietarv Name Manufacturer Clearance Alpha Mirage@Top Tightening Alphatec Manufacturing, K930515, K951846 Spinal System with titanium alloy Inc. KO20356 rods The new commercially pure tit…
Alphatec Mfg., Inc.1994—
*K951846Mirage Spinal System for Severe Spondylolisthesis
Summary page 3
…ate device: Trade/Proprietarv Name Manufacturer Clearance Alpha Mirage@Top Tightening Alphatec Manufacturing, K930515, K951846 Spinal System with titanium alloy Inc. KO20356 rods The new commercially pure titanium rod…
Alphatec Mfg., Inc.1996—
*K020356Alpha Mirage Top Tightening Spinal SystemAlphatec Mfg., Inc.2002—

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 4 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
  • None of the 4 ancestors has a recall.

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.

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?

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 (Le.…

Read the full statement (256 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 (Le., 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 tumor 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-Sl) vertebral joint.

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

a. Patients having fractures of thoracic and lumbar spine.

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

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

Indications for use as stated in the FDA summary.

More from Alphatec Mfg., Inc.

20 FDA decisions under this applicant name. See the company

  • K033090Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc. · 20041 recall
  • K020356Alpha 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 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/K023299 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023299: 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/K023299

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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