510(k) Report

510(k) · Cleared

Cleared

ST360 Degrees Spinal Fixation System

K133291510(k) TraditionalCleared Dec 17, 201353-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

Zimmer Spine, Inc. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Dec 17, 2013 as substantially equivalent to K022374 (Sulzer Spine-Tech, 2002) and 2 other predicates after a 53-day review. Its family tree reaches back 5 generations to 1998. 1 later device descends from it.

Decided
Dec 17, 2013
Review
53 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
3

Its longest line of descent runs back 5 generations to K980288 (1998). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2015: 1 descendant clearedK980288 · Spine-Tech Silhouette Spinal Fixation System · Spine-Tech, Inc. · 1998K992276 · Modification to Silhouette Spinal Fixation System · Sulzer Spine-Tech · 1999K022374 · Cadence Spinal Fixation System · Sulzer Spine-Tech · 2002 · recalledK041925 · ST360 Spinal Fixation System · Zimmer Spine, Inc. · 2004 · recalledK072183 · ST360 Spinal Fixation System, Model 07.0029-7500.5600 · Zimmer Spine, Inc. · 20071995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant K072183 · ST360 Spinal Fixation System, Model 07.0029-7500.5600 · Zimmer Spine, Inc. · 2007K041925 · ST360 Spinal Fixation System · Zimmer Spine, Inc. · 2004 · recalledK022374 · Cadence Spinal Fixation System · Sulzer Spine-Tech · 2002 · recalledK992276 · Modification to Silhouette Spinal Fixation System · Sulzer Spine-Tech · 1999K980288 · Spine-Tech Silhouette Spinal Fixation System · Spine-Tech, Inc. · 1998−50
  1. Root · 5 generations backK980288 Spine-Tech Silhouette Spinal Fixation SystemSpine-Tech, Inc. · 1998
  2. 4 generations backK992276 Modification to Silhouette Spinal Fixation SystemSulzer Spine-Tech · 1999
  3. 3 generations backK022374 Cadence Spinal Fixation SystemSulzer Spine-Tech · 2002 · Recalled
  4. 2 generations backK041925 ST360 Spinal Fixation SystemZimmer Spine, Inc. · 2004 · Recalled
  5. 1 generation backK072183 ST360 Spinal Fixation System, Model 07.0029-7500.5600Zimmer Spine, Inc. · 2007
  6. This deviceK133291 ST360 Degrees Spinal Fixation SystemZimmer Spine, Inc. · 2013
  7. Descendant · cites it directly · 0 of its ownK142752 Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal…Zimmer Spine, Inc. · 2015

Most influential descendants

Showing 1 of 1 · See all
  • K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System…Zimmer Spine, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K980288Spine-Tech Silhouette Spinal Fixation SystemSpine-Tech, Inc.1998—
−4K992276Modification to Silhouette Spinal Fixation SystemSulzer Spine-Tech1999—
−3K022374Cadence Spinal Fixation SystemSulzer Spine-Tech20021
−2K041925ST360 Spinal Fixation SystemZimmer Spine, Inc.20041
−1K072183ST360 Spinal Fixation System, Model 07.0029-7500.5600Zimmer Spine, Inc.2007—
0 (this device)K133291ST360 Degrees Spinal Fixation SystemZimmer Spine, Inc.2013—
+1K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation…Zimmer Spine, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
FIG. 1 — Lineage of K133291, 1998–2015Source: 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 NKB? 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 NKB device

  1. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K022374Cadence Spinal Fixation System
Summary page 1
…e Devices: The modified ST360®@ Spinal Fixation System is substantially equivalent to the legally marketed predicate device, ST360 0 ® Spinal Fixation System cleared in K022374, K041925 and K072183. Zimmer Spine - 510(k) - ST360®@ Spinal Fixation SystemK139 -P…
Sulzer Spine-Tech20021
*K041925ST360 Spinal Fixation System
Summary page 1
…: The modified ST360®@ Spinal Fixation System is substantially equivalent to the legally marketed predicate device, ST360 0 ® Spinal Fixation System cleared in K022374, K041925 and K072183. Zimmer Spine - 510(k) - ST360®@ Spinal Fixation SystemK139 -Pae2o3…
Zimmer Spine, Inc.20041
*K072183ST360 Spinal Fixation System, Model 07.0029-7500.5600
Summary page 1
…ied ST360®@ Spinal Fixation System is substantially equivalent to the legally marketed predicate device, ST360 0 ® Spinal Fixation System cleared in K022374, K041925 and K072183. Zimmer Spine - 510(k) - ST360®@ Spinal Fixation SystemK139 -Pae2o3 General Dev…
Zimmer Spine, Inc.2007—

Also cleared against K022374: 2 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System…Zimmer Spine, Inc.20150

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 15 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
  • 2 of the 5 ancestors have a recall of any class.
  • Of its descendants, K142752 (Zimmer Spine, Inc., 2015) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K022374.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

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

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, 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
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

What is it indicated for?

The ST360 Spinal Fixation System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor…

Read the full statement (195 words)

The ST360 Spinal Fixation System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. Pedicle screw fixation is limited to skeletally mature patients.

When used as a sacral screw system, the ST360 Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined as chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic, deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the ST360 Spinal Fixation System are intended for the sacral iliac attachment only. Transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for sacral screw fixation of this system are T1 to the sacrum.

Indications for use as stated in the FDA summary.

Also cleared against K022374

2 other devices cite the same predicate.

  • K072183ST360 Spinal Fixation System, Model 07.0029-7500.5600Zimmer Spine, Inc. · 2007
  • K041925ST360 Spinal Fixation SystemZimmer Spine, Inc. · 20041 recall

More from Zimmer Spine, Inc.

52 FDA decisions under this applicant name. See the company

  • K153631Zimmer Virage OCT Spinal Fixation SystemZimmer Spine, Inc. · 2016
  • K150896Vitality Spinal Fixation SystemZimmer Spine, Inc. · 20153 recalls
  • K151031Virage OCT Spinal Fixation SystemZimmer Spine, Inc. · 2015
  • K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical…Zimmer Spine, Inc. · 2015
  • K143626inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix…Zimmer Spine, Inc. · 2015

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K133291 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133291: ST360 Degrees Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133291

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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