510(k) Report

510(k) · Cleared

Cleared

Synthes (U.S.a.) Universal Spinal Parallel Connector

K962608510(k) TraditionalCleared Dec 9, 1996159-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

Synthes (Usa) · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Dec 9, 1996 after a 159-day review. The FDA summary names its predicate without a number. 94 later devices descend from it.

Decided
Dec 9, 1996
Review
159 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
0

94 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2012: 5 descendants cleared2014: 3 descendants cleared2017: 12 descendants cleared2018: 4 descendants cleared2021: 7 descendants cleared2016: 3 descendants cleared2015: 5 descendants cleared2024: 12 descendants cleared2019: 5 descendants cleared2020: 6 descendants cleared2025: 9 descendants cleared2023: 9 descendants cleared2022: 6 descendants cleared2026: 8 descendants cleared1995200020052010201520202025
  1. This deviceK962608 Synthes (U.S.a.) Universal Spinal Parallel ConnectorSynthes (Usa) · 1996
  2. Descendant · cites it directly · 93 of its ownK113149 Synthes Uss ConnectorsSynthes Spine · 2012
  3. Descendant · 2 generations on · 74 of its ownK120571 Synthes Uss ConnectorSynthes Spine · 2012
  4. Descendant · 3 generations on · 67 of its ownK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
  5. Descendant · 4 generations on · 30 of its ownK143248 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014
  6. Descendant · 5 generations on · 26 of its ownK150856 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015

Showing 5 of 94 descendants. See all descendants

Descendants cleared per year

2012: 52014: 32015: 52016: 32017: 122018: 42019: 52020: 62021: 72022: 62023: 92024: 122025: 92026: 8
2012high 12 (2017) · low 0 (2013)2026

Most influential descendants

Showing 5 of 94 · See all
  • K113149Synthes Uss ConnectorsSynthes Spine · 2012 · cites it directly93descendants
  • K120571Synthes Uss ConnectorSynthes Spine · 2012 · 2 generations on74descendants
  • K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · 3 generations on67descendants
  • K143248Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014 · 4 generations on30descendants
  • K150856Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015 · 5 generations on26descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K962608Synthes (U.S.a.) Universal Spinal Parallel ConnectorSynthes (Usa)1996—
+1K113149Synthes Uss ConnectorsSynthes Spine2012—
+2K120571Synthes Uss ConnectorSynthes Spine2012—
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)20141
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.2014—
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201250
201430
201550
201630
2017120
201840
201950
202060
202170
202260
202390
2024120
202590
202680
FIG. 1 — Lineage of K962608, 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.

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? (2)

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
*—Texas Scottish Rite Hospital (TSRH) Crosslink Axial Plate
Named without a submission number
—
*—Cotrel Dubosset (CD) System Domino
Named without a submission number
—

What descends from it? (94)

See all 94

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K113149Synthes Uss ConnectorsSynthes Spine201293

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?

  • Of its descendants, K113149 (Synthes Spine, 2012) has gone furthest, with 93 descendants of its own.

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 pedicle screw system, the Synthes Universal Spinal Parallel Connector is intended for patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lunbar-first sacral (L5-S1) vertebral joint; who are receiving fusions using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine; and who are having the device removed after the development of a solid fusion. When used as a nonpedicle…

Read the full statement (130 words)

When used as a pedicle screw system, the Synthes Universal Spinal Parallel Connector is intended for patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lunbar-first sacral (L5-S1) vertebral joint; who are receiving fusions using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine; and who are having the device removed after the development of a solid fusion.

When used as a nonpedicle screw system, it is also intended for scoliotic, lordotic, or kyphotic deformities (such as scoliosis, Schueremann’s disease); degenerauve disk disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; and fractures of the posterior thoracolumbar spine (levels T8-S2). The overall levels of fixation are T8-S2.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Synthes (Usa)

406 FDA decisions under this applicant name. See the company

  • K131984Synthes Synsonic Ulna NailSynthes (Usa) · 2014
  • K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 20111 recall
  • K111540Synthes 3.5MM LCP Clavicle Plate SystemSynthes (Usa) · 2011
  • K110789Synthes Sternal Zipfix SystemSynthes (Usa) · 20113 recalls
  • K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 20112 recalls

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/K962608 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962608: Synthes (U.S.a.) Universal Spinal Parallel Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962608

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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