510(k) Report

510(k) · Cleared

Cleared

Arctec Semirigid Plating System

K051044510(k) TraditionalCleared Oct 7, 2005165-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

Altiva Corp. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Oct 7, 2005 as substantially equivalent to K930353 (Smith & Nephew, Inc., 1995) and 4 other predicates after a 165-day review. Its family tree reaches back 2 generations to 1996.

Decided
Oct 7, 2005
Review
165 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K955348 (1996). 7 ancestors in all, the oldest K930353 (1995). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor1998: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestor1997: 1 other ancestorK955348 · Titanium Moss Miami Spinal System · Depuy, Inc. · 1996K964024 · Depuy Motech Titanium Moss Miami Spinal System · Depuy, Inc. · 1997199619982000200220042006
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 1 other ancestor K964024 · Depuy Motech Titanium Moss Miami Spinal System · Depuy, Inc. · 1997K955348 · Titanium Moss Miami Spinal System · Depuy, Inc. · 19960
  1. Root · 2 generations backK955348 Titanium Moss Miami Spinal SystemDepuy, Inc. · 1996
  2. 1 generation backK964024 Depuy Motech Titanium Moss Miami Spinal SystemDepuy, Inc. · 1997
  3. This deviceK051044 Arctec Semirigid Plating SystemAltiva Corp. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K955348Titanium Moss Miami Spinal SystemDepuy, Inc.1996—
−1K964024Depuy Motech Titanium Moss Miami Spinal SystemDepuy, Inc.1997—
0 (this device)K051044Arctec Semirigid Plating SystemAltiva Corp.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199610
199710
199810
200510
FIG. 1 — Lineage of K051044, 1996–2005Source: 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? (5)

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
*K930353Simmons Plating System Bolt and Screw
Summary page 1
…Pedicle screw spinal system 21 CFR 888.3070, Class II MNH, MNI VI. PREDICATE DEVICE INFORMATION: Simmons Stainless Steel Plating System (K930353) Ultium Plating System (K962784) HydraLok System (KO51216) Rogozinski Spinal System (K983899) Titaniu…
Smith & Nephew, Inc.1995—
*K962784Ultium Spinal Plating System
Summary page 1
…21 CFR 888.3070, Class II MNH, MNI VI. PREDICATE DEVICE INFORMATION: Simmons Stainless Steel Plating System (K930353) Ultium Plating System (K962784) HydraLok System (KO51216) Rogozinski Spinal System (K983899) Titanium Moss Miami Spinal System (K964024)…
Smith & Nephew, Inc., Orthopaedic Div.1996—
*K051216Hydralok System
Cleared while this submission was under review
Altiva Corp.20051
*K983899Thoracolumbar Spinal Rod System (Empower)
Summary page 1
…RMATION: Simmons Stainless Steel Plating System (K930353) Ultium Plating System (K962784) HydraLok System (KO51216) Rogozinski Spinal System (K983899) Titanium Moss Miami Spinal System (K964024) VII. DEVICE DESCRIPTION: The ArcTeCTM Semi-Rigid Plating System in…
United States Surgical, A Division of Tyco Healthc1998—
*K964024Depuy Motech Titanium Moss Miami Spinal System
Summary page 1
…tem (K930353) Ultium Plating System (K962784) HydraLok System (KO51216) Rogozinski Spinal System (K983899) Titanium Moss Miami Spinal System (K964024) VII. DEVICE DESCRIPTION: The ArcTeCTM Semi-Rigid Plating System includes plates, bolts, washers and locking nuts in…
Depuy, Inc.1997—

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 2 companies; a new generation was cleared every 8.5 years on median.
  • 1 of the 7 ancestors has a recall of any class.

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 ArcTecTM Semi-Rigid Plating System is intended for posterior, noncervical, pedicle fixation in order 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, including degenerative spondylolisthesis with objective evidence of neurological impairment; fracture…

Read the full statement (133 words)

The ArcTecTM Semi-Rigid Plating System is intended for posterior, noncervical, pedicle fixation in order 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, including degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the ArcTecTM Semi-Rigid Plating System is intended for skeletally mature patients with severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attainment of solid fusion.

Indications for use as stated in the FDA summary.

More from Altiva Corp.

5 FDA decisions under this applicant name. See the company

  • K070891Altiva Classic Acp SystemAltiva Corp. · 2007
  • K061482Altes Buttress Plating SystemAltiva Corp. · 2006
  • K053070Contour II Spinal SystemAltiva Corp. · 2006
  • K051216Hydralok SystemAltiva Corp. · 20051 recall

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/K051044 · printed Nov 4, 2026

Cite this page

510(k) Report. “K051044: Arctec Semirigid Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051044

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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