510(k) · Cleared

Cleared

Titanium Spinal Rod System

K980862510(k) TraditionalCleared May 20, 199876-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 May 20, 1998 as substantially equivalent to K970635 (Smith & Nephew, Inc., Orthopaedic Div., 1997) after a 76-day review. Its family tree reaches back 1 generation to 1997. 4 later devices descend from it.

Decided: May 20, 1998
Review: 76 days
Class: Class II
Product code: MNH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K970635 (1997). 4 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK970635 Titanium Spinal Rod SystemSmith & Nephew, Inc., Orthopaedic Div. · 1997
This deviceK980862 Titanium Spinal Rod SystemUnited States Surgical, A Division of Tyco Healthc · 1998
Descendant · cites it directly · 3 of its ownK983197 Surgical Dynamics Rodding System (Previously Known as the Aurora…United States Surgical, A Division of Tyco Healthc · 1998
Descendant · 2 generations on · 2 of its ownK992784 Next Generation Rodding SystemUnited States Surgical, A Division of Tyco Healthc · 1999
Descendant · 3 generations on · 1 of its ownK000009 Spiral Radius Rodding SystemUnited States Surgical, A Division of Tyco Healthc · 2000
Descendant · 3 generations on · 0 of its ownK012273 Spiral Radius 90-D SST SystemUnited States Surgical, A Division of Tyco Healthc · 2001

Most influential descendants

Showing 4 of 4 · See all

K983197Surgical Dynamics Rodding System (Previously Known as the Aurora Titanium Spinal Rod…United States Surgical, A Division of Tyco Healthc · 1998 · cites it directly3descendants
K992784Next Generation Rodding SystemUnited States Surgical, A Division of Tyco Healthc · 1999 · 2 generations on2descendants
K000009Spiral Radius Rodding SystemUnited States Surgical, A Division of Tyco Healthc · 2000 · 3 generations on1descendant
K012273Spiral Radius 90-D SST SystemUnited States Surgical, A Division of Tyco Healthc · 2001 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K970635	Titanium Spinal Rod System	Smith & Nephew, Inc., Orthopaedic Div.	1997	—
0 (this device)	K980862	Titanium Spinal Rod System	United States Surgical, A Division of Tyco Healthc	1998	—
+1	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	—
+3	K000009	Spiral Radius Rodding System	United States Surgical, A Division of Tyco Healthc	2000	—
+3	K012273	Spiral Radius 90-D SST System	United States Surgical, A Division of Tyco Healthc	2001	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	1	0
2000	1	0
2001	1	0

FIG. 1 — Lineage of K980862, 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K970635	Titanium Spinal Rod System Summary page 1 …COMMON NAME: Titanium Spinal Rod System PROPRIETARY NAME: Titanium Spinal Rod System PREDICATE DEVICES: ¢ USSC's (formerly Smith & Nephew's) Titanium Spinal Rod System (K970635) & USSC’s (formerly Smith & Nephew’s) Rogozinski Spinal Rod System INTENDED USE: The components of the Titanium Spinal Rod Syste…	Smith & Nephew, Inc., Orthopaedic Div.	1997	—
*	—	USSC’s (formerly Smith & Nephew’s) Rogozinski Spinal Rod System Named without a submission number			—

Also cleared against K970635: 5 other devices →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K983197	Surgical Dynamics Rodding System (Previously Known as the Aurora Titanium Spinal Rod…	United States Surgical, A Division of Tyco Healthc	1998	3

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, K983197 (United States Surgical, A Division of Tyco Healthc, 1998) has gone furthest, with 3 descendants of its own.
5 other devices also cite its predicate K970635.

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 Titanium Spinal Rod 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 spine. 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…

Read the full statement (324 words)

The components of the Titanium Spinal Rod 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 spine. 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, multi-operated back or revision of previous surgery.

When used as a nonpedicle posterior system consisting of hooks, crosslinks and sacralfiliac screws the levels of attachment are the lumbar, thoracic and cervical spine and the 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 sacral/iliac screw fixation to the noncervical 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),. tumors, pseudoarthrosis, multi-operated back or revision of previous surgery.

When used as a posterior pedicle system consisting of hooks, crosslinks, sacral/iliac screws, pedicle screws and connectors the levels of attachment are lumbar, thoracic and cervical spine and the sacrum and ilium. The device system using pedicle screws is intended 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; and (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 levels of pedicle screw fixation may be L3-S1.

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/K980862 · printed Nov 5, 2026

Cite this page

510(k) Report. “K980862: Titanium Spinal Rod System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980862

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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