510(k) Report

510(k) · Cleared

Recalled · Class II · 2022

Sterispine™ PS

K201648510(k) TraditionalCleared Jul 30, 202042-day reviewClass II21 CFR 888.3070Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Safe Orthopaedics · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Jul 30, 2020 as substantially equivalent to K170528 (Safe Orthopaedics, 2017) and 9 other predicates after a 42-day review. Its family tree reaches back 14 generations to 2004. 1 later device descends from it. It has been recalled once.

Decided
Jul 30, 2020
Review
42 days
Class
Class II
Product code
NKB
Recalls
1
Predicates
10

Its longest line of descent runs back 14 generations to K040583 (2004). 106 ancestors in all, the oldest K841189 (1984). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2017: 1 other ancestor2015: 4 other ancestors2014: 1 other ancestor2013: 1 other ancestor2012: 1 other ancestor2011: 3 other ancestors2001: 10 other ancestors2010: 3 other ancestors2009: 2 other ancestors2004: 19 other ancestors2008: 2 other ancestors2006: 7 other ancestors2005: 10 other ancestors2003: 6 other ancestors2002: 5 other ancestors2000: 5 other ancestors1999: 2 other ancestors2007: 2 other ancestors1996: 1 other ancestor1998: 2 other ancestors1997: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor1992: 1 other ancestor1984: 1 other ancestor2026: 1 descendant cleared×7: 7 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004), K043151 (2005), K050809 (2005), K052187 (2005), K053101 (2006) ×2: 2 generations cleared close together, K091442 (2009), K091974 (2009) K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010×2: 2 generations cleared close together, K112473 (2011), K113174 (2011) K152604 · KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set · Medtronic Sofamor Danek USA, Incorporated · 2016K170347 · CD HORIZON™ Fenestrated Screw Set · Medtronic Sofamor Danek USA · 201719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors2 generations back: 1 other ancestor3 generations back: 5 other ancestors4 generations back: 22 other ancestors5 generations back: 23 other ancestors6 generations back: 22 other ancestors7 generations back: 10 other ancestors 1 generation forward: 1 descendant K170347 · CD HORIZON™ Fenestrated Screw Set · Medtronic Sofamor Danek USA · 2017K152604 · KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set · Medtronic Sofamor Danek USA, Incorporated · 2016K113174 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011 · recalledK112473 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2011K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010K091974 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2009 · recalledK091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2009K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006K052187 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K050809 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2005K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K042025 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2004 · recalledK041118 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K040583 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2004−10−50
  1. Root · 14 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 10 generations between
  3. 3 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  4. 2 generations backK152604 KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated · 2016
  5. 1 generation backK170347 CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA · 2017
  6. This deviceK201648 Sterispine™ PSSafe Orthopaedics · 2020
  7. Descendant · cites it directly · 0 of its ownK260989 Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI) · 2026
Show all 14 generations
  1. Root · 14 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 13 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 12 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 11 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 10 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 9 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 8 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 7 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 6 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 5 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 4 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 3 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 2 generations backK152604 KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated · 2016
  14. 1 generation backK170347 CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA · 2017
  15. This deviceK201648 Sterispine™ PSSafe Orthopaedics · 2020

Most influential descendants

Showing 1 of 1 · See all
  • K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI) · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−13K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−12K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−11K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−10K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−9K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−8K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−7K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−6K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−5K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−4K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−3K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−2K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016—
−1K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA2017—
0 (this device)K201648Sterispine™ PSSafe Orthopaedics2020—
+1K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199210
199410
199510
199610
199710
199820
199920
200050
2001100
200250
200360
2004190
2005100
200670
200720
200820
200920
201030
201130
201210
201310
201410
201540
201710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K201648, 2004–2026Source: 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? (10)

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
*K170528Sterispine™ PS
Summary page 4
…section 888.3070 Device panel ORTHOPEDIC Primary predicate: Sterispine™ PS manufactured by SAFE ORTHOPAEDICS (K170528) Additional predicates: CD HORIZON™ Fenestrated Screw Set manufactured by Legally marketed…
Safe Orthopaedics2017—
*K170347CD HORIZON™ Fenestrated Screw Set
Summary page 4
…(K170528) Additional predicates: CD HORIZON™ Fenestrated Screw Set manufactured by Legally marketed Medtronic Sofamor Danek (K170347), Synergy 4.0 mm, 4.5 mm VLS screws predicate devices manufactured by Interpore Cross Intl (K011437), Steris…
Medtronic Sofamor Danek USA2017—
*K011437Synergy 4.0 MM, 4.5 MM VLS Screws
Summary page 4
…ed Medtronic Sofamor Danek (K170347), Synergy 4.0 mm, 4.5 mm VLS screws predicate devices manufactured by Interpore Cross Intl (K011437), Sterispine™ Ps manufactured by SAFE ORTHOPAEDICS (K151921, K151747, K150092, K140802, K130632, K121299,…
Interpore Cross Intl.2001—
*K151921Sterispine PS
Summary page 4
…VLS screws predicate devices manufactured by Interpore Cross Intl (K011437), Sterispine™ Ps manufactured by SAFE ORTHOPAEDICS (K151921, K151747, K150092, K140802, K130632, K121299, K112453)…
Safe Orthopaedics2015—
*K151747Sterispine PS
Summary page 4
…ws predicate devices manufactured by Interpore Cross Intl (K011437), Sterispine™ Ps manufactured by SAFE ORTHOPAEDICS (K151921, K151747, K150092, K140802, K130632, K121299, K112453)…
Safe Orthopaedics2015—
*K150092STERISPINE PS Pedicle Screw
Summary page 4
…ate devices manufactured by Interpore Cross Intl (K011437), Sterispine™ Ps manufactured by SAFE ORTHOPAEDICS (K151921, K151747, K150092, K140802, K130632, K121299, K112453)…
Safe Orthopaedics2015—
*K140802Sterispine PS
Summary page 4
…es manufactured by Interpore Cross Intl (K011437), Sterispine™ Ps manufactured by SAFE ORTHOPAEDICS (K151921, K151747, K150092, K140802, K130632, K121299, K112453)…
Safe Orthopaedics2014—
*K130632Sterispine PS Pedicle Screw
Summary page 4
…manufactured by Interpore Cross Intl (K011437), Sterispine™ Ps manufactured by SAFE ORTHOPAEDICS (K151921, K151747, K150092, K140802, K130632, K121299, K112453)…
Safe Orthopaedics2013—
*K121299Sterispineps Pedicle Screw, Sterispineps Rod
Summary page 4
…manufactured by Interpore Cross Intl (K011437), Sterispine™ Ps manufactured by SAFE ORTHOPAEDICS (K151921, K151747, K150092, K140802, K130632, K121299, K112453)…
Safe Orthopaedics2012—
*K112453Sterispineps Pedicle Screw
Summary page 4
…e Cross Intl (K011437), Sterispine™ Ps manufactured by SAFE ORTHOPAEDICS (K151921, K151747, K150092, K140802, K130632, K121299, K112453) <ϮϬϭϲϰϴ…
Safe Orthopaedics2011—

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 3, 2022Class IIZ-1572-2022Labeling Change ControlThe type of screw printed on the traceability record for the patient label is incorrect, but the type of screw printed on the other labeling is correct.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 5 months on median.
  • 19 of the 106 ancestors have a recall of any class.
  • Of its descendants, K260989 (Kyocera Medical Technologies Inc. (KMTI), 2026) has gone furthest, with 0 descendants of its own.

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. 2020, 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 Sterispine™ PS system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct of fusion. Sterispine™ PS 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 ; tumor ; pseudoarthrosis and failed previous fusion.

Indications for use as stated in the FDA summary.

More from Safe Orthopaedics

13 FDA decisions under this applicant name. See the company

  • K170528Sterispine™ PSSafe Orthopaedics · 2017
  • K162531Sterispine CCSafe Orthopaedics · 2016
  • K151921Sterispine PSSafe Orthopaedics · 2015
  • K151747Sterispine PSSafe Orthopaedics · 2015
  • K151756Sterispine LC CageSafe Orthopaedics · 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/K201648 · printed Nov 6, 2026

Cite this page

510(k) Report. “K201648: Sterispine™ PS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201648

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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