510(k) Report

510(k) · Cleared

Cleared

Thoracolumbar Spinal Rod System (Empower)

K983899510(k) TraditionalCleared Dec 22, 199849-day reviewClass II21 CFR 888.3060

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 · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Dec 22, 1998 as substantially equivalent to K965224 (Smith & Nephew Richards, Inc., 1997) after a 49-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.

Decided
Dec 22, 1998
Review
49 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K965224 (1997). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant clearedK965224 · Empower Anterior Direct Screws · Smith & Nephew Richards, Inc. · 19971995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant K965224 · Empower Anterior Direct Screws · Smith & Nephew Richards, Inc. · 19970
  1. Root · 1 generation backK965224 Empower Anterior Direct ScrewsSmith & Nephew Richards, Inc. · 1997
  2. This deviceK983899 Thoracolumbar Spinal Rod System (Empower)United States Surgical, A Division of Tyco Healthc · 1998
  3. Descendant · cites it directly · 0 of its ownK051044 Arctec Semirigid Plating SystemAltiva Corp. · 2005

Most influential descendants

Showing 1 of 1 · See all
  • K051044Arctec Semirigid Plating SystemAltiva Corp. · 2005 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K965224Empower Anterior Direct ScrewsSmith & Nephew Richards, Inc.1997—
0 (this device)K983899Thoracolumbar Spinal Rod System (Empower)United States Surgical, A Division of Tyco Healthc1998—
+1K051044Arctec Semirigid Plating SystemAltiva Corp.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
FIG. 1 — Lineage of K983899, 1997–2005Source: 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 KWQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KWQ device

  1. #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK854696FDA’s K854696 is OP II Visible Light Curing System
Our OCR of the scanned summary read K854696, FDA’s number for OP II Visible Light Curing System (Almore Intl., Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “USSC's Surgical Dynamics™ Thoracolumbar Spinal Rod (Empower) System”. Kept off the family tree.
Summary page 1
…Spondylolisthesis Spinal Fixation Device System Spinal Rod System Thoracolumbar Spinal Rod System USSC's Surgical Dynamics™ Thoracolumbar Spinal Red (Empower) System — K854696, K965224 The Thoracolumbar Spinal Rod System consists of stainless steel rods attached to the spinal celumn through the use of i…
Almore Intl., Inc.1986—
*K965224Empower Anterior Direct Screws
Summary page 1
…isthesis Spinal Fixation Device System Spinal Rod System Thoracolumbar Spinal Rod System USSC's Surgical Dynamics™ Thoracolumbar Spinal Red (Empower) System — K854696, K965224 The Thoracolumbar Spinal Rod System consists of stainless steel rods attached to the spinal celumn through the use of interlamin…
Smith & Nephew Richards, Inc.1997—

Also cleared against K965224: 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.

NumberDeviceApplicantDecidedDescendants
K051044Arctec Semirigid Plating SystemAltiva Corp.20050

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, K051044 (Altiva Corp., 2005) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K965224.

How does its category compare?

All KWQ devices

KWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWQ

7in 2025

2007: 272008: 322009: 232010: 232011: 222012: 262013: 222014: 172015: 252016: 152017: 202018: 222019: 262020: 262021: 172022: 182023: 162024: 172025: 72026 (partial year): 10
2007high 32 (2008) · low 7 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWQ

64in 2025

2007: 101 days median2008: 70 days median2009: 90 days median2010: 104 days median2011: 95 days median2012: 90 days median2013: 88 days median2014: 124 days median2015: 102 days median2016: 121 days median2017: 67 days median2018: 95 days median2019: 81 days median2020: 55 days median2021: 59 days median2022: 85 days median2023: 59 days median2024: 64 days median2025: 64 days median2026 (partial year): 76 days median
2007high 124 (2014) · low 55 (2020)2026

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

Recalls per year · KWQ

1in 2018

2007: 22008: 332009: 352010: 22011: 52012: 72013: 62015: 22016: 92017: 82018: 1
2007high 35 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWQ

248in 2025

2007: 2882008: 3482009: 3552010: 6912011: 4152012: 5442013: 7962014: 5462015: 5622016: 5022017: 4922018: 3412019: 2982020: 4002021: 5912022: 3922023: 3202024: 4192025: 248
2007high 796 (2013) · low 248 (2025)2025

MAUDE reports naming product code KWQ, 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
2007271012288
2008327033348
2009239035355
2010231042691
201122955415
201226907544
201322886796
2014171240546
2015251022562
2016151219502
201720678492
201822951341
201926810298
202026550400
202117590591
202218850392
202316590320
202417640419
20257640248
202610760—

What is it indicated for?

Non-Pedicle Screw Fixation When used as an anterior spinal system the Thoracolumbar Spinal Rod System is intended for the treatement of DOD (degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies), pseudoarthrosis, stenosis, deformities (scoliosis, kyphosis, lordosis), spondylolisthesis, fracture, previous failed fusion, or tumor resection. The Thoracolumbar Spinal…

Read the full statement (293 words)

Non-Pedicle Screw Fixation

When used as an anterior spinal system the Thoracolumbar Spinal Rod System is intended for the treatement of DOD (degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies), pseudoarthrosis, stenosis, deformities (scoliosis, kyphosis, lordosis), spondylolisthesis, fracture, previous failed fusion, or tumor resection. The Thoracolumbar Spinal Rod System is limited to non-cervical use.

When used as a posterior, non-pedicie spinal system (consisting of hooks and sacralliliac screws), the Thoracolumbar Spinal Rod System is intended for the treatement of DDD (degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies), pseudoarthrosis, stenosis, deformities (scoliosis, kyohosis, lordosis), spondylolisthesis, fracture, previous failed fusion, or tumor resection. The Thoracelumbar Spinal Rod System is limited to non-cervical use.

Pedicle Screw Fixation

When used as a pedicle screw system, in the spine of skeletally mature patients, the Thoracolumbar Spinal Rod 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 btone 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 remaved after the development of a solid fusion mass.

In addition, when used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Thoracolumbar Spinal Rod 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, kyphesis, spinal tumor, and failed previous fusion (pseudarthrosis).

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 K965224

1 other device cites the same predicate.

  • K983904Rogozinski Spinal Rod SystemUnited States Surgical, A Division of Tyco Healthc · 1998

More from United States Surgical, A Division of…

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  • K071920Autosuture Absorbable Tack and ApplicatorUnited States Surgical, A Division of Tyco Healthc · 2007
  • K061288Auto Suture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2006
  • K062850Autosuture Circular Eea Surgical StaplersUnited States Surgical, A Division of Tyco Healthc · 2006
  • K062326Autosuture Modified Versaport Trocar with Fixation SleeveUnited States Surgical, A Division of Tyco Healthc · 2006

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https://510kreport.com/device/K983899 · printed Nov 5, 2026

Cite this page

510(k) Report. “K983899: Thoracolumbar Spinal Rod System (Empower).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983899

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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