510(k) Report

510(k) · Cleared

Cleared

Orthobiom Spinal System

K071668510(k) TraditionalCleared Jul 2, 2008379-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

Paradigm Spine · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Jul 2, 2008 as substantially equivalent to K781443 (Orthopedic Equipment Co., Inc., 1978) and 4 other predicates after a 379-day review. Its family tree reaches back 2 generations to 1996. 1 of the 590 devices in its family, counting itself, has a Class I recall. 582 later devices descend from it.

Decided
Jul 2, 2008
Review
379 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K953915 (1996). 7 ancestors in all, the oldest K781443 (1978). 582 later devices descend from it, 3 citing it directly. 1 of the 590 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2000: 2 other ancestors1998: 1 other ancestor1996: 1 other ancestor1978: 1 other ancestor2010: 2 descendants cleared2012: 15 descendants cleared2011: 5 descendants cleared2023: 59 descendants cleared2013: 24 descendants cleared2014: 32 descendants cleared2015: 41 descendants cleared2018: 39 descendants cleared2024: 59 descendants cleared2016: 35 descendants cleared2019: 26 descendants cleared2026: 48 descendants cleared2017: 40 descendants cleared2021: 31 descendants cleared, 1 with a Class I recall12020: 36 descendants cleared2022: 40 descendants cleared2025: 50 descendants clearedK953915 · Moss Miami Spinal System (Anterior Use) · Depuy, Inc. · 1996K012916 · Frontier Anterior Scoliosis System · Depuy Acromed, Inc. · 200119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 51 descendants3 generations forward: 116 descendants4 generations forward: 164 descendants, 1 with a Class I recall15 generations forward: 101 descendants6 generations forward: 64 descendants7 generations forward: 46 descendants8 generations forward: 23 descendants9 generations forward: 11 descendants10 generations forward: 3 descendants K012916 · Frontier Anterior Scoliosis System · Depuy Acromed, Inc. · 2001K953915 · Moss Miami Spinal System (Anterior Use) · Depuy, Inc. · 19960+5+10
  1. Root · 2 generations backK953915 Moss Miami Spinal System (Anterior Use)Depuy, Inc. · 1996
  2. 1 generation backK012916 Frontier Anterior Scoliosis SystemDepuy Acromed, Inc. · 2001
  3. This deviceK071668 Orthobiom Spinal SystemParadigm Spine · 2008
  4. Descendant · cites it directly · 581 of its ownK091445 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010
  5. Descendant · 2 generations on · 269 of its ownK110070 TSRH Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2011
  6. Descendant · 2 generations on · 261 of its ownK111457 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2011
  7. Descendant · 2 generations on · 260 of its ownK113395 Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012
  8. Descendant · cites it directly · 251 of its ownK113666 Xia 3 Spinal SystemStryker Spine · 2012

Showing 5 of 582 descendants. See all descendants

Descendants cleared per year

2010: 22011: 52012: 152013: 242014: 322015: 412016: 352017: 402018: 392019: 262020: 362021: 312022: 402023: 592024: 592025: 502026: 48
2010high 59 (2023) · low 2 (2010)2026

Class I recalls in this family

  • K211616 ExcelsiusHub4 generations on · 2021

Most influential descendants

Showing 5 of 582 · See all
  • K091445CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010 · cites it directly581descendants
  • K110070TSRH Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2011 · 2 generations on269descendants
  • K111457CD Horizon Spinal SystemMedtronic Sofamor Danek · 2011 · 2 generations on261descendants
  • K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012 · 2 generations on260descendants
  • K113666Xia 3 Spinal SystemStryker Spine · 2012 · cites it directly251descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K953915Moss Miami Spinal System (Anterior Use)Depuy, Inc.1996—
−1K012916Frontier Anterior Scoliosis SystemDepuy Acromed, Inc.2001—
0 (this device)K071668Orthobiom Spinal SystemParadigm Spine2008—
+1K091445CD Horizon Spinal SystemMedtronic Sofamor Danek2010—
+2K110070TSRH Spinal SystemMedtronic Sofamor Danck USA, Inc.2011—
+2K111457CD Horizon Spinal SystemMedtronic Sofamor Danek2011—
+2K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012—
+1K113666Xia 3 Spinal SystemStryker Spine2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
199610
199810
200020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201020
201150
2012150
2013240
2014320
2015410
2016350
2017400
2018390
2019260
2020360
2021311
2022400
2023590
2024590
2025500
2026480
FIG. 1 — Lineage of K071668, 1996–2026Source: 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.

1 device in this family has a Class I recall. 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? (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
*K781443Harrington Spine Instrumentation
Summary page 1
…stantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used. These predicates include Harrington Rods (K781443), Synthes Small Stature USS (K994121), DePuy Spine Kaneda Spinal System (K974757), Acromed Pediatric ISOLA (K962984), and DePuy S…
Orthopedic Equipment Co., Inc.1978—
*K994121Small Stature Uss
Summary page 1
…leared devices and has the same indications for use, design, function, and materials used. These predicates include Harrington Rods (K781443), Synthes Small Stature USS (K994121), DePuy Spine Kaneda Spinal System (K974757), Acromed Pediatric ISOLA (K962984), and DePuy Spine Frontier Anterior Deformity Syst…
Synthes (Usa)2000—
*K974757Kaneda Anterior Scoliosis System Kass
Summary page 1
…for use, design, function, and materials used. These predicates include Harrington Rods (K781443), Synthes Small Stature USS (K994121), DePuy Spine Kaneda Spinal System (K974757), Acromed Pediatric ISOLA (K962984), and DePuy Spine Frontier Anterior Deformity System (K012916). Performance Standards: Testin…
Acromed Corp.1998—
*K962984Isola Pediatric Components
Summary page 1
…rials used. These predicates include Harrington Rods (K781443), Synthes Small Stature USS (K994121), DePuy Spine Kaneda Spinal System (K974757), Acromed Pediatric ISOLA (K962984), and DePuy Spine Frontier Anterior Deformity System (K012916). Performance Standards: Testing performed indicate that the Ortho…
Acromed Corp.1996—
*K012916Frontier Anterior Scoliosis System
Summary page 1
…, Synthes Small Stature USS (K994121), DePuy Spine Kaneda Spinal System (K974757), Acromed Pediatric ISOLA (K962984), and DePuy Spine Frontier Anterior Deformity System (K012916). Performance Standards: Testing performed indicate that the OrthobiomTM Spinal System is as mechanically sound as predicate dev…
Depuy Acromed, Inc.2001—

Also cleared against K781443: 1 other device →

What descends from it? (582)

See all 582

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K091445CD Horizon Spinal SystemMedtronic Sofamor Danek2010581
K113666Xia 3 Spinal SystemStryker Spine2012251
K121630Range Spinal SystemK2m, Inc.2012127

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 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 6.6 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K091445 (Medtronic Sofamor Danek, 2010) has gone furthest, with 581 descendants of its own.
  • 1 other device also cites its predicate K781443.

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. 2008, 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 OrthobiomTM Spinal System is a posterior, non-cervical pedicle screw system indicated to treat pediatric scoliosis by (1) correction, (2) stabilization, (3) adjustment and (4) fixation of the scoliotic spine.

The Orthobiom TM Spinal System is intended to be used with bone graft.

Indications for use as stated in the FDA summary.

Also cleared against K781443

1 other device cites the same predicate.

  • K161028K2M Growing Spine SystemK2m, Inc. · 2016

More from Paradigm Spine

3 FDA decisions under this applicant name. See the company

  • K213493Fortilink with TiPlus TechnologyParadigm Spine · 2022
  • K080963DSS Stabilization SystemParadigm Spine · 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/K071668 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071668: Orthobiom Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071668

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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