510(k) Report

510(k) · Cleared

Cleared

Single Planar Multi Axial (Spma) Pedicle Screw System

K070295510(k) TraditionalCleared May 21, 2007110-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

Trinity Orthopedics, LLC · MNI Orthosis, Spinal Pedicle Fixation

Cleared on May 21, 2007 as substantially equivalent to K955348 (Depuy, Inc., 1996) and 9 other predicates after a 110-day review. Its family tree reaches back 6 generations to 1995.

Decided
May 21, 2007
Review
110 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
11

Its longest line of descent runs back 6 generations to K950697 (1995). 41 ancestors in all, the oldest K933881 (1994). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestor2005: 3 other ancestors2002: 3 other ancestors2000: 4 other ancestors1998: 2 other ancestors1996: 5 other ancestors2003: 4 other ancestors2001: 2 other ancestors1999: 2 other ancestors1997: 2 other ancestors1995: 3 other ancestors1994: 1 other ancestor2004: 3 other ancestorsK950697 · Depuy Motech Moss Miami Spinal System - Pedicle Fixation · Depuy Motech · 1995K050461 · Xia 4.5 Spinal System · Stryker Spine · 2005K052761 · Modification to: Xia 4.5 Spinal System · Stryker Spine · 2005K060361 · Xia Spinal System, Xia 4.5 Spinal System · Stryker Spine · 2006 · recalledK061854 · Xia Titanium Spinal System and Xia Stainless Steel Spinal System · Stryker Spine · 2006K063428 · Xia Stainless Steel Spinal System · Stryker Spine · 20061990199520002005
Other ancestors, by generation 1 generation back: 9 other ancestors2 generations back: 16 other ancestors3 generations back: 8 other ancestors4 generations back: 2 other ancestors K063428 · Xia Stainless Steel Spinal System · Stryker Spine · 2006K061854 · Xia Titanium Spinal System and Xia Stainless Steel Spinal System · Stryker Spine · 2006K060361 · Xia Spinal System, Xia 4.5 Spinal System · Stryker Spine · 2006 · recalledK052761 · Modification to: Xia 4.5 Spinal System · Stryker Spine · 2005K050461 · Xia 4.5 Spinal System · Stryker Spine · 2005K950697 · Depuy Motech Moss Miami Spinal System - Pedicle Fixation · Depuy Motech · 1995−50
  1. Root · 6 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
  2. 5 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
  3. 4 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
  4. 3 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
  5. 2 generations backK061854 Xia Titanium Spinal System and Xia Stainless Steel Spinal SystemStryker Spine · 2006
  6. 1 generation backK063428 Xia Stainless Steel Spinal SystemStryker Spine · 2006
  7. This deviceK070295 Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K950697Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech1995—
−5K050461Xia 4.5 Spinal SystemStryker Spine2005—
−4K052761Modification to: Xia 4.5 Spinal SystemStryker Spine2005—
−3K060361Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine20061
−2K061854Xia Titanium Spinal System and Xia Stainless Steel Spinal SystemStryker Spine2006—
−1K063428Xia Stainless Steel Spinal SystemStryker Spine2006—
0 (this device)K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199530
199650
199720
199820
199920
200040
200120
200230
200340
200430
200530
200610
FIG. 1 — Lineage of K070295, 1995–2007Source: 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? (11)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK001971FDA’s K001971 is Hemodialysis Tubing Sets
Our reading of the summary gave K001971, FDA’s number for Hemodialysis Tubing Sets (Ofi Biomedica S.P.A.). Its FDA name has none of the distinctive words the summary uses for the device it names, “OPTIMA Spinal System”. Kept off the family tree.
Ofi Biomedica S.P.A.2001—
*K955348Titanium Moss Miami Spinal System
Summary page 3
…en determined by FDA to be substantially equivalent to pre-amendment devices: OPTIMA~'T Spinal System (KO0i1971) from U & I Corporation, the MOSS®'Miami Spinal System (K955348, K98251 1, K983583, K022623) from DePuy AcroMed, Inc., the Stryker Xia® Spinal System (KO01 272, K043473, K060979, K063428) from…
Depuy, Inc.1996—
*K982511Depuy Motech Moss Miami Spinal Systems
Summary page 3
…ined by FDA to be substantially equivalent to pre-amendment devices: OPTIMA~'T Spinal System (KO0i1971) from U & I Corporation, the MOSS®'Miami Spinal System (K955348, K98251 1, K983583, K022623) from DePuy AcroMed, Inc., the Stryker Xia® Spinal System (KO01 272, K043473, K060979, K063428) from Stryker Sp…
Depuy, Inc.1998—
*K983583Depuy Acromed Moss and Moss Miami Spinal Systems
Summary page 3
…A to be substantially equivalent to pre-amendment devices: OPTIMA~'T Spinal System (KO0i1971) from U & I Corporation, the MOSS®'Miami Spinal System (K955348, K98251 1, K983583, K022623) from DePuy AcroMed, Inc., the Stryker Xia® Spinal System (KO01 272, K043473, K060979, K063428) from Stryker Spine, and…
Depuy, Inc.1998—
*K0226235.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)
Summary page 3
…ubstantially equivalent to pre-amendment devices: OPTIMA~'T Spinal System (KO0i1971) from U & I Corporation, the MOSS®'Miami Spinal System (K955348, K98251 1, K983583, K022623) from DePuy AcroMed, Inc., the Stryker Xia® Spinal System (KO01 272, K043473, K060979, K063428) from Stryker Spine, and the CD HO…
Depuyacromed2002—
*K001272Xia Spine SystemHowmedica Osteonics Corp.2000—
*K043473Modification to Xia Spinal System
Summary page 3
…KO0i1971) from U & I Corporation, the MOSS®'Miami Spinal System (K955348, K98251 1, K983583, K022623) from DePuy AcroMed, Inc., the Stryker Xia® Spinal System (KO01 272, K043473, K060979, K063428) from Stryker Spine, and the CD HORIZON® Spinal System (K961633, K001 255) from Medtroniic Sofamnor Danek, Inc.…
Stryker Spine2005—
*K060979Xia Titanium and 4.5 Spinal Systems
Summary page 3
…from U & I Corporation, the MOSS®'Miami Spinal System (K955348, K98251 1, K983583, K022623) from DePuy AcroMed, Inc., the Stryker Xia® Spinal System (KO01 272, K043473, K060979, K063428) from Stryker Spine, and the CD HORIZON® Spinal System (K961633, K001 255) from Medtroniic Sofamnor Danek, Inc. The SPM…
Stryker Spine2006—
*K063428Xia Stainless Steel Spinal System
Summary page 3
…I Corporation, the MOSS®'Miami Spinal System (K955348, K98251 1, K983583, K022623) from DePuy AcroMed, Inc., the Stryker Xia® Spinal System (KO01 272, K043473, K060979, K063428) from Stryker Spine, and the CD HORIZON® Spinal System (K961633, K001 255) from Medtroniic Sofamnor Danek, Inc. The SPMA Pedicle…
Stryker Spine2006—
*K961633CD Horizon Spinal System
Summary page 3
…, K983583, K022623) from DePuy AcroMed, Inc., the Stryker Xia® Spinal System (KO01 272, K043473, K060979, K063428) from Stryker Spine, and the CD HORIZON® Spinal System (K961633, K001 255) from Medtroniic Sofamnor Danek, Inc. The SPMA Pedicle Screw System has the following similarities to the predicate de…
Sofamor Danek USA,Inc.1996—
*K001255CD Horizon Spinal System
Summary page 3
…, K022623) from DePuy AcroMed, Inc., the Stryker Xia® Spinal System (KO01 272, K043473, K060979, K063428) from Stryker Spine, and the CD HORIZON® Spinal System (K961633, K001 255) from Medtroniic Sofamnor Danek, Inc. The SPMA Pedicle Screw System has the following similarities to the predicate devices:…
Medtronic Sofamor Danek, Inc.2000—

Also cleared against K955348: 33 other devices →

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 12 years and passes through 3 companies; a new generation was cleared every 5 months on median.
  • 2 of the 41 ancestors have a recall of any class.
  • 33 other devices also cite its predicate K955348.

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. 2007, this device’s year, is highlighted.

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?

The Single Planar Multi Axial (SPMA) Pedicle Screw System is 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, spinal stenosis, dislocation, scoliosis, kyphosis, lordosis, spinal tumor, pseudoarthrosis, and failed previous fusion.

Indications for use as stated in the FDA summary.

Also cleared against K955348

33 other devices cite the same predicate.

  • K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System…Medos International SARL · 2019
  • K190376PASS LP Spinal SystemMedicrea International SA · 20195 recalls
  • K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC · 2018
  • K180324Patriot Spinal Fixation SystemValorus Spine · 2018
  • K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd. · 2017
  • K153404Zavation Spinal SystemZavation, LLC · 2016

More from Trinity Orthopedics, LLC

2 FDA decisions under this applicant name. See the company

  • K081790Modification to Single Planar Multi Axis (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC · 2008

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/K070295 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070295: Single Planar Multi Axial (Spma) Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070295

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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