510(k) · Cleared

Cleared

SSCS (Segmental Spinal Correction System)

K971289510(k) TraditionalCleared Jun 18, 199772-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 Jun 18, 1997 as substantially equivalent to K955173 (Osteotech, Inc., 1996) after a 72-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.

Decided: Jun 18, 1997
Review: 72 days
Class: Class II
Product code: KWP
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K955173 (1996). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK955173 SSCS (Segmental Spinal Correction System)Osteotech, Inc. · 1996
This deviceK971289 SSCS (Segmental Spinal Correction System)Osteotech, Inc. · 1997
Descendant · cites it directly · 0 of its ownK973868 SSCS (Segmental Spinal Correction System)Osteotech, Inc. · 1998

Most influential descendants

Showing 1 of 1 · See all

K973868SSCS (Segmental Spinal Correction System)Osteotech, Inc. · 1998 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K955173	SSCS (Segmental Spinal Correction System)	Osteotech, Inc.	1996	—
0 (this device)	K971289	SSCS (Segmental Spinal Correction System)	Osteotech, Inc.	1997	—
+1	K973868	SSCS (Segmental Spinal Correction System)	Osteotech, Inc.	1998	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

FIG. 1 — Lineage of K971289, 1996–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (4)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K955173	SSCS (Segmental Spinal Correction System) Summary page 1 …Orthosis; Spondylolisthesis Spinal Fixation Device System 3. Devices to Which New Device is Substantially Equivalent: Trade/Proprigtary/Model Name Manufacturer SSCS (K955173) Heinrich C. Ulrnich ISOLA Acromed TSRH Sofamor-Danek CD (Cotrel-Dubousset) Sofamor-Danek Y 4. Device Description: The SSCS (…	Osteotech, Inc.	1996	—
*	—	ISOLA Named without a submission number			—
*	—	TSRH Named without a submission number			—
*	—	CD (Cotrel-Dubousset) Named without a submission number			—

Also cleared against K955173: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K973868	SSCS (Segmental Spinal Correction System)	Osteotech, Inc.	1998	0

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?

Its one ancestor has no recall.
Of its descendants, K973868 (Osteotech, Inc., 1998) has gone furthest, with 0 descendants of its own.
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

2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007high 186 (2010) · low 50 (2008)2026

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

Recalls per year · KWP

2in 2022

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	14	96	2	210
2008	13	50	1	594
2009	12	89	23	682
2010	14	186	2	474
2011	12	67	6	792
2012	18	112	1	918
2013	12	99	3	1,090
2014	13	138	0	1,022
2015	9	113	1	1,348
2016	0	—	3	1,379
2017	0	—	0	864
2018	0	—	1	657
2019	0	—	2	518
2020	0	—	0	796
2021	0	—	0	525
2022	0	—	2	335
2023	0	—	0	332
2024	0	—	0	436
2025	0	—	0	494
2026	0	—	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.

https://510kreport.com/device/K971289 · printed Nov 6, 2026

Cite this page

510(k) Report. “K971289: 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/K971289

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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