510(k) · Cleared

Cleared

Spiral Radius 90-D SST System

K012273510(k) SpecialCleared Aug 15, 200127-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

United States Surgical, A Division of Tyco Healthc · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Aug 15, 2001 as substantially equivalent to K992784 (United States Surgical, A Division of Tyco Healthc, 1999) and 2 other predicates after a 27-day review. Its family tree reaches back 5 generations to 1997.

Decided: Aug 15, 2001
Review: 27 days
Class: Class II
Product code: MNH
Recalls: None
Predicates: 3

Its longest line of descent runs back 5 generations to K970635 (1997). 8 ancestors in all, the oldest K954696 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK970635 Titanium Spinal Rod SystemSmith & Nephew, Inc., Orthopaedic Div. · 1997
4 generations backK974213 Aurora Titanium Spinal Rod SystemUnited States Surgical, A Division of Tyco Healthc · 1998
3 generations backK983197 Surgical Dynamics Rodding System (Previously Known as the Aurora…United States Surgical, A Division of Tyco Healthc · 1998
2 generations backK992784 Next Generation Rodding SystemUnited States Surgical, A Division of Tyco Healthc · 1999
1 generation backK000009 Spiral Radius Rodding SystemUnited States Surgical, A Division of Tyco Healthc · 2000
This deviceK012273 Spiral Radius 90-D SST SystemUnited States Surgical, A Division of Tyco Healthc · 2001

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K970635	Titanium Spinal Rod System	Smith & Nephew, Inc., Orthopaedic Div.	1997	—
−4	K974213	Aurora Titanium Spinal Rod System	United States Surgical, A Division of Tyco Healthc	1998	—
−3	K983197	Surgical Dynamics Rodding System (Previously Known as the Aurora Titanium…	United States Surgical, A Division of Tyco Healthc	1998	—
−2	K992784	Next Generation Rodding System	United States Surgical, A Division of Tyco Healthc	1999	—
−1	K000009	Spiral Radius Rodding System	United States Surgical, A Division of Tyco Healthc	2000	—
0 (this device)	K012273	Spiral Radius 90-D SST System	United States Surgical, A Division of Tyco Healthc	2001	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1998	2	0

FIG. 1 — Lineage of K012273, 1997–2001Source: 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 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

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What was it cleared against? (3)

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
*	K992784	Next Generation Rodding System Summary page 1 …Spinal Fixation Device System Stainless Steel Spinal Rod System PROPRIETARY NAME: Spiral Radius 90-D™ SST System PREDICATE DEVICES: USS’s Spiral Radius 90-D™ System — K992784 & INTENDED USE: K000009 & the Rogozinski Spinal Rodding System — K954696 The components of the Spiral Radius 90-D™ SST System…	United States Surgical, A Division of Tyco Healthc	1999	—
*	K000009	Spiral Radius Rodding System Summary page 1 …tem Stainless Steel Spinal Rod System PROPRIETARY NAME: Spiral Radius 90-D™ SST System PREDICATE DEVICES: USS’s Spiral Radius 90-D™ System — K992784 & INTENDED USE: K000009 & the Rogozinski Spinal Rodding System — K954696 The components of the Spiral Radius 90-D™ SST System are indicated for spinal f…	United States Surgical, A Division of Tyco Healthc	2000	—
*	K954696	Rogozinski Thoracolumbar Spinal Rod Summary page 1 …RY NAME: Spiral Radius 90-D™ SST System PREDICATE DEVICES: USS’s Spiral Radius 90-D™ System — K992784 & INTENDED USE: K000009 & the Rogozinski Spinal Rodding System — K954696 The components of the Spiral Radius 90-D™ SST System are indicated for spinal fixation. When used as an anterolateral/anterior…	Smith & Nephew Richards, Inc.	1996	—

Also cleared against K992784: 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 4 years and passes through 2 companies; a new generation was cleared every 9 months on median.
None of the 8 ancestors has a recall.
1 other device also cites its predicate K992784.

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

2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007high 171 (2011) · low 65 (2008)2026

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

Recalls per year · MNH

1in 2016

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	5	123	0	18
2008	13	65	0	30
2009	13	151	7	45
2010	10	106	0	59
2011	17	171	0	107
2012	7	93	1	433
2013	10	124	1	464
2014	12	140	0	286
2015	10	99	0	152
2016	8	93	1	216
2017	0	—	0	174
2018	0	—	0	129
2019	0	—	0	403
2020	0	—	0	432
2021	0	—	0	531
2022	0	—	0	265
2023	0	—	0	121
2024	0	—	0	302
2025	0	—	0	89
2026	0	—	0	—

What is it indicated for?

The components of the Spiral Radius 90-D™ SST System are indicated for spinal fixation. When used as an anterolateral/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spines. The points of attachment and methods are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T6-L5) and the anterior vertebral bodies of the cervical spine. The indications are…

Read the full statement (358 words)

The components of the Spiral Radius 90-D™ SST System are indicated for spinal fixation.

When used as an anterolateral/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spines. The points of attachment and methods are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T6-L5) and the anterior vertebral bodies of the cervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion (pseudoarthrosis).

When used as a nonpedicle posterior system consisting of hooks, crosslinks and sacralfiliac screws the levels of attachments are the lumbar, thoracic and cervical spine and sacrum and ilium. Intended uses include hook and sacral screw fixation to the lumbar spine, noncervical spine and to the T1-S1 spine; and hook and sacralfiliac screw fixation to the noncervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, pseudoarthrosis, or failed previous fusion (pseudoarthrosis).

When used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Spiral Radius 90-D™ SST System is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 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 (L3 and below); and (d) who are having the device removed after the development of solid fusion mass.

In addition, when used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Spiral Radius 90-D™ SST System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

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/K012273 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012273: Spiral Radius 90-D SST System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012273

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026