510(k) Report

510(k) · Cleared

Cleared

Synthes Spine Universal Spinal Hook, Rod, Pedicle/Sacral Screw Fixation System

K980928510(k) TraditionalCleared May 11, 199861-day reviewClass II21 CFR 888.3050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Synthes Spine · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on May 11, 1998 as substantially equivalent to K964254 (Sofamor Danek USA,Inc., 1997) and 1 other predicate after a 61-day review. Its family tree reaches back 1 generation to 1997.

Decided
May 11, 1998
Review
61 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K964254 (1997). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestorK964254 · Titanium Liberty Posterior Spinal System · Sofamor Danek USA,Inc. · 1997199619982000
Other ancestors, by generation 1 generation back: 1 other ancestor K964254 · Titanium Liberty Posterior Spinal System · Sofamor Danek USA,Inc. · 19970
  1. Root · 1 generation backK964254 Titanium Liberty Posterior Spinal SystemSofamor Danek USA,Inc. · 1997
  2. This deviceK980928 Synthes Spine Universal Spinal Hook, Rod, Pedicle/Sacral Screw…Synthes Spine · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K964254Titanium Liberty Posterior Spinal SystemSofamor Danek USA,Inc.1997—
0 (this device)K980928Synthes Spine Universal Spinal Hook, Rod, Pedicle/Sacral Screw Fixation SystemSynthes Spine1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K980928, 1997–1998Source: 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 KWP? 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? (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
*K964254Titanium Liberty Posterior Spinal System
Summary page 1
…E. Sands Paoli, PA 19301 1/28/98 Device: SYNTHES Spine Universal Spinal Hook, Rod, Pedicle/Sacral Screw Fixation System compared to the Liberty Posterior Spinal System (K964254) and the Titanium Spinal Rod System (K970635). The Synthes Universal Spinal Hook, Rod, Pedicle/Sacral Screw Fixation System curr…
Sofamor Danek USA,Inc.1997—
*K970635Titanium Spinal Rod System
Summary page 1
…THES Spine Universal Spinal Hook, Rod, Pedicle/Sacral Screw Fixation System compared to the Liberty Posterior Spinal System (K964254) and the Titanium Spinal Rod System (K970635). The Synthes Universal Spinal Hook, Rod, Pedicle/Sacral Screw Fixation System currently consists of rods, hooks, clamps and scr…
Smith & Nephew, Inc., Orthopaedic Div.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?

  • None of the 2 ancestors has a recall.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWP

9in 2015

2007: 142008: 132009: 122010: 142011: 122012: 182013: 122014: 132015: 9
2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007: 96 days median2008: 50 days median2009: 89 days median2010: 186 days median2011: 67 days median2012: 112 days median2013: 99 days median2014: 138 days median2015: 113 days median
2007high 186 (2010) · low 50 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWP

2in 2022

2007: 22008: 12009: 232010: 22011: 62012: 12013: 32015: 12016: 32018: 12019: 22022: 2
2007high 23 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWP

494in 2025

2007: 2102008: 5942009: 6822010: 4742011: 7922012: 9182013: 1,0902014: 1,0222015: 1,3482016: 1,3792017: 8642018: 6572019: 5182020: 7962021: 5252022: 3352023: 3322024: 4362025: 494
2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, 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
200714962210
200813501594
2009128923682
2010141862474
201112676792
2012181121918
2013129931,090
20141313801,022
2015911311,348
20160—31,379
20170—0864
20180—1657
20190—2518
20200—0796
20210—0525
20220—2335
20230—0332
20240—0436
20250—0494
20260—0—

What is it indicated for?

When used as a posterior pedicle screw fixation system, the Synthes Universal Spinal Hook, Rod and Pedicle/Sacral Screw Fixation System is intended for patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-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…

Read the full statement (165 words)

When used as a posterior pedicle screw fixation system, the Synthes Universal Spinal Hook, Rod and Pedicle/Sacral Screw Fixation System is intended for patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-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 mass.

When used as a posterior, non-pedicle screw fixation system, the Universal Spinal Hook, Rod and Pedicle/Sacral Screw Fixation System is also intended for scoliotic, lordotic, or kyphotic deformities (such as scoliosis, Scheuermann’s disease); degenerative disk disease (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 T4-S2). In addition, when using the parallel rod connector, the USS can be connected to the Posterior Cervical/Thoracic Hook/Rod System.

The overall levels of fixation are T4-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 Spine

36 FDA decisions under this applicant name. See the company

  • K122211Synthes Navigable Pedicle Preparation InstrumentsSynthes Spine · 2012
  • K120838Synthes Matrix SystemSynthes Spine · 2012
  • K111048Synthes Scout Tack FixationSynthes Spine · 2012
  • K120928Synthes Matrix SystemSynthes Spine · 2012
  • K120571Synthes Uss ConnectorSynthes Spine · 2012

Recent decisions in KWP

The KWP category page

  • K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2015
  • K150753OASYS SystemStryker Corporation · 2015
  • K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
  • K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
  • K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 20153 recalls

https://510kreport.com/device/K980928 · printed Nov 5, 2026

Cite this page

510(k) Report. “K980928: Synthes Spine Universal Spinal Hook, Rod, Pedicle/Sacral Screw Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980928

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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