510(k) Report

510(k) · Cleared

Cleared

SSCS (Segmental Spinal Correction System)

K973868510(k) TraditionalCleared Jan 8, 199890-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

Osteotech, Inc. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Jan 8, 1998 as substantially equivalent to K955173 (Osteotech, Inc., 1996) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1996.

Decided
Jan 8, 1998
Review
90 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K955173 (1996). No later device cites it as a predicate yet.

K955173 · SSCS (Segmental Spinal Correction System) · Osteotech, Inc. · 1996K971289 · SSCS (Segmental Spinal Correction System) · Osteotech, Inc. · 1997199619982000
K971289 · SSCS (Segmental Spinal Correction System) · Osteotech, Inc. · 1997K955173 · SSCS (Segmental Spinal Correction System) · Osteotech, Inc. · 19960
  1. Root · 2 generations backK955173 SSCS (Segmental Spinal Correction System)Osteotech, Inc. · 1996
  2. 1 generation backK971289 SSCS (Segmental Spinal Correction System)Osteotech, Inc. · 1997
  3. This deviceK973868 SSCS (Segmental Spinal Correction System)Osteotech, Inc. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K955173SSCS (Segmental Spinal Correction System)Osteotech, Inc.1996—
−1K971289SSCS (Segmental Spinal Correction System)Osteotech, Inc.1997—
0 (this device)K973868SSCS (Segmental Spinal Correction System)Osteotech, Inc.1998—
FIG. 1 — Lineage of K973868, 1996–1998Source: 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? (6)

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
*K955173SSCS (Segmental Spinal Correction System)
Summary page 1
…Orthosis; Spondylolisthesis Spinal Fixation Device System 3. Devices to Which New Device is Substantially Equivalent: Trade/Proprietary/Model Name Manufacturer SSCS (K955173:K971289) Heinrich C. Ulrich ISOLA Acromed TSRH Sofamor-Danek CD (Cotrel-Dubousset) Sofamor-Danek USS Synthes 4. Device Descript…
Osteotech, Inc.1996—
*K971289SSCS (Segmental Spinal Correction System)
Summary page 1
…is; Spondylolisthesis Spinal Fixation Device System 3. Devices to Which New Device is Substantially Equivalent: Trade/Proprietary/Model Name Manufacturer SSCS (K955173:K971289) Heinrich C. Ulrich ISOLA Acromed TSRH Sofamor-Danek CD (Cotrel-Dubousset) Sofamor-Danek USS Synthes 4. Device Description: Th…
Osteotech, Inc.1997—
*—ISOLA
Named without a submission number
—
*—TSRH
Named without a submission number
—
*—CD (Cotrel-Dubousset)
Named without a submission number
—
*—USS
Named without a submission number
—

Also cleared against K955173: 1 other device →

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 2 years and passes through 1 company; a new generation was cleared every 1.4 years on median.
  • None of the 2 ancestors has a recall.
  • 1 other device also cites its predicate K955173.

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?

The SSCS is intended for use as a posterior spinal fixation device, with specific indications as follows: 1) When used as a thoracic/lumbar hook or sacral screw and hook system, the SSCS is intended for instrumentation of the spine at levels ranging from T1 to S2 and is indicated for: - scoliosis - kyphosis - spinal fractures - degenerative disc disease, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and…

Read the full statement (190 words)

The SSCS is intended for use as a posterior spinal fixation device, with specific indications as follows:

1) When used as a thoracic/lumbar hook or sacral screw and hook system, the SSCS is intended for instrumentation of the spine at levels ranging from T1 to S2 and is indicated for:

- scoliosis

- kyphosis

- spinal fractures

- degenerative disc disease, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

- tumors

- stenosis

- spondylolisthesis

- pseudoarthrosis

- previously failed attempts at spinal fusion

2) When used as a sacral/pedicle screw system, the SSCS is intended for patients:

a. Having severe spondylolisthesis (grade 3 or 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint

b. Who are receiving fusions using autogenous bone graft only.

c. Who are having the device fixed or attached to the lumbar and sacral spine.

d. Who are having the device removed after the development of a solid fusion mass.

Although the levels of fusion may not go above the L5-S1 joint, the SSCS screws may be inserted into pedicles up to, but not above, L-3.

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

Also cleared against K955173

1 other device cites the same predicate.

  • K971289SSCS (Segmental Spinal Correction System)Osteotech, Inc. · 1997

More from Osteotech, Inc.

24 FDA decisions under this applicant name. See the company

  • K082615Grafton R II Edbm, Demineralized Bone Matrix Allograft, Resorbable Calcium Salt Bone Void Filler DevicesOsteotech, Inc. · 20081 recall
  • K081227Plexur MOsteotech, Inc. · 2008
  • K080511Plexur-POsteotech, Inc. · 2008
  • K073405Plexur MOsteotech, Inc. · 2008
  • K061982Plexur POsteotech, Inc. · 2007

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/K973868 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973868: SSCS (Segmental Spinal Correction System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973868

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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