510(k) Report

510(k) · Cleared

Cleared

Omniaxial Connector

K993926510(k) SpecialCleared Dec 17, 199929-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

Ortho Tec, LLC · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Dec 17, 1999 as substantially equivalent to K983353 (Orthotec, Inc., 1998) after a 29-day review. Its family tree reaches back 5 generations to 1990.

Decided
Dec 17, 1999
Review
29 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K901587 (1990). 16 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 2 other ancestors1994: 1 other ancestor1993: 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. · 1997×2: 2 generations cleared close together, K973836 (1998), K974749 (1998) K983353 · SCS Spinal System · Orthotec, Inc. · 1998199019921994199619982000
Other ancestors, by generation 2 generations back: 1 other ancestor3 generations back: 10 other ancestors K983353 · SCS Spinal System · Orthotec, Inc. · 1998K974749 · Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior and Posterior Spinal Systems · Cross Medical Products, 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 backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
  5. 1 generation backK983353 SCS Spinal SystemOrthotec, Inc. · 1998
  6. This deviceK993926 Omniaxial ConnectorOrtho Tec, LLC · 1999
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—
−2K974749Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy…Cross Medical Products, Inc.1998—
−1K983353SCS Spinal SystemOrthotec, Inc.1998—
0 (this device)K993926Omniaxial ConnectorOrtho Tec, LLC1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199250
199320
199410
199520
FIG. 1 — Lineage of K993926, 1990–1999Source: 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 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? (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
*K983353SCS Spinal System
Summary page 1
…): KWP KWQ & MNH, MNT 4, Equivalent Predicate Device: The OmniAxial Connector may be directly contrasted with the earlier screw-rod connector of the SCS Spinal System, K983353. The OmniAxial Connector performs essentially the same function as the orniginal connector. The basic design, dimensional toleran…
Orthotec, Inc.1998—

Also cleared against K983353: 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 9 years and passes through 5 companies; a new generation was cleared every 12 months on median.
  • None of the 16 ancestors has a recall.
  • 1 other device also cites its predicate K983353.

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?

When used as a nonpedicle posterior system, the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis fracture spinal stenosis deformities (i.e., scoliosis, kyphosis, lordosis) tumors pseudarthrosis failed previous fusion (pseudarthrosis) When used as an anterolateral/anterior system the SCS system is…

Read the full statement (224 words)

When used as a nonpedicle posterior system, the SCS system is indicated for patients with:

degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies

spondylolisthesis

fracture

spinal stenosis

deformities (i.e., scoliosis, kyphosis, lordosis)

tumors

pseudarthrosis

failed previous fusion (pseudarthrosis)

When used as an anterolateral/anterior system the SCS system is indicated for patients with:

degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies

spondylolisthesis

fracture

spinal stenosis

deformities (i.e., scoliosis, kyphosis, lordosis)

tumors

pseudarthrosis

failed previous fusion (pseudarthrosis)

When used as a posterior pedicle system, the device is indicated for use in skeletally mature patients L3 & below who are:

having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint

receiving fusions using autogenous bone graft only

having the device fixed or attached to the lumbar and sacral spine

having the device removed after the development of a solid fusion mass.

Posterior pedicle systems are 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 neurologic impairment

fracture

dislocation

scoliosis

kyphosis

spinal tumor

failed previous fusion (pseudarthrosis)

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 K983353

1 other device cites the same predicate.

  • K9942885.0MM Spinal ScrewsOrtho Tec, LLC · 2000

More from Ortho Tec, LLC

22 FDA decisions under this applicant name. See the company

  • K040514Eovia Calcium Phosphate CeramicOrtho Tec, LLC · 2004
  • K040346Modification to Oria Top Clip SystemOrtho Tec, LLC · 2004
  • K030958Oria Spinal System, Domino and Tube ConnectorsOrtho Tec, LLC · 2003
  • K031471Oria Spinal Clip System, Lateral Intermediate Connector, Model AL01Ortho Tec, LLC · 2003
  • K023884Modification Oria Spinal SystemOrtho Tec, LLC · 2003

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/K993926 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993926: Omniaxial Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993926

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