510(k) · Cleared
ClearedSterispine™ PS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Safe Orthopaedics · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Mar 9, 2017 as substantially equivalent to K112453 (Safe Orthopaedics, 2011) and 5 other predicates after a 15-day review. Its family tree reaches back 10 generations to 1992. 2 later devices descend from it.
- Decided
- Mar 9, 2017
- Review
- 15 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 10 generations to K921873 (1992). 21 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK921873 Quickanchor, ModificationMitek Surgical Products, Inc. · 1992
- 6 generations between
- 3 generations backK130632 Sterispine PS Pedicle ScrewSafe Orthopaedics · 2013
- 2 generations backK140802 Sterispine PSSafe Orthopaedics · 2014
- 1 generation backK151747 Sterispine PSSafe Orthopaedics · 2015
- This deviceK170528 Sterispine™ PSSafe Orthopaedics · 2017
- Descendant · cites it directly · 1 of its ownK201648 Sterispine™ PSSafe Orthopaedics · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK260989 Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI) · 2026
Show all 10 generations
- Root · 10 generations backK921873 Quickanchor, ModificationMitek Surgical Products, Inc. · 1992
- 9 generations backK992487 Mitek Mini Quickanchor PlusMitek Products · 1999
- 8 generations backK061349 Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006
- 7 generations backK090615 Opus Speedlock Knotless Fixation DeviceArthrocare Corp. · 2009 · Recalled
- 6 generations backK101437 Speedfix Suture SystemArthrocare Corp. · 2010
- 5 generations backK112453 Sterispineps Pedicle ScrewSafe Orthopaedics · 2011
- 4 generations backK121299 Sterispineps Pedicle Screw, Sterispineps RodSafe Orthopaedics · 2012
- 3 generations backK130632 Sterispine PS Pedicle ScrewSafe Orthopaedics · 2013
- 2 generations backK140802 Sterispine PSSafe Orthopaedics · 2014
- 1 generation backK151747 Sterispine PSSafe Orthopaedics · 2015
- This deviceK170528 Sterispine™ PSSafe Orthopaedics · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K921873 | Quickanchor, Modification | Mitek Surgical Products, Inc. | 1992 | — |
| −9 | K992487 | Mitek Mini Quickanchor Plus | Mitek Products | 1999 | — |
| −8 | K061349 | Opus Labralock P Knotless Fixation Device | Arthrocare Corp. | 2006 | — |
| −7 | K090615 | Opus Speedlock Knotless Fixation Device | Arthrocare Corp. | 2009 | 1 |
| −6 | K101437 | Speedfix Suture System | Arthrocare Corp. | 2010 | — |
| −5 | K112453 | Sterispineps Pedicle Screw | Safe Orthopaedics | 2011 | — |
| −4 | K121299 | Sterispineps Pedicle Screw, Sterispineps Rod | Safe Orthopaedics | 2012 | — |
| −3 | K130632 | Sterispine PS Pedicle Screw | Safe Orthopaedics | 2013 | — |
| −2 | K140802 | Sterispine PS | Safe Orthopaedics | 2014 | — |
| −1 | K151747 | Sterispine PS | Safe Orthopaedics | 2015 | — |
| 0 (this device) | K170528 | Sterispine™ PS | Safe Orthopaedics | 2017 | — |
| +1 | K201648 | Sterispine™ PS | Safe Orthopaedics | 2020 | 1 |
| +2 | K260989 | Varion Thoracolumbar Fixation System | Kyocera Medical Technologies Inc. (KMTI) | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2026 | 1 | 0 |
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 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 | Decided |
|---|---|---|---|
| * | K112453 | Sterispineps Pedicle ScrewSummary page 4…uct code NKB CFR section 888.3070 Device panel Orthopedic Legally marketed predicate Primary predicate: Sterispine™ PS K112453, devices Additional predicates: Sterispine™ PS K121299, K130632, K140802, K1517… | 2011 |
| * | K121299 | Sterispineps Pedicle Screw, Sterispineps RodSummary page 4…nel Orthopedic Legally marketed predicate Primary predicate: Sterispine™ PS K112453, devices Additional predicates: Sterispine™ PS K121299, K130632, K140802, K151747, K151921) Indications for use The Sterispine™ PS system is inten… | 2012 |
| * | K130632 | Sterispine PS Pedicle ScrewSummary page 4…Orthopedic Legally marketed predicate Primary predicate: Sterispine™ PS K112453, devices Additional predicates: Sterispine™ PS K121299, K130632, K140802, K151747, K151921) Indications for use The Sterispine™ PS system is intended to pr… | 2013 |
| * | K140802 | Sterispine PSSummary page 4…Orthopedic Legally marketed predicate Primary predicate: Sterispine™ PS K112453, devices Additional predicates: Sterispine™ PS K121299, K130632, K140802, K151747, K151921) Indications for use The Sterispine™ PS system is intended to provide imm… | 2014 |
| * | K151747 | Sterispine PSSummary page 4…e Primary predicate: Sterispine™ PS K112453, devices Additional predicates: Sterispine™ PS K121299, K130632, K140802, K151747, K151921) Indications for use The Sterispine™ PS system is intended to provide immobilization… | 2015 |
| * | K151921 | Sterispine PSSummary page 4…ry predicate: Sterispine™ PS K112453, devices Additional predicates: Sterispine™ PS K121299, K130632, K140802, K151747, K151921) Indications for use The Sterispine™ PS system is intended to provide immobilization and st… | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201648 | Sterispine™ PS | 2020 | 1 |
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 25 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 21 ancestors have a recall of any class.
- Of its descendants, K201648 (Safe Orthopaedics, 2020) has gone furthest, with 1 descendant of its own.
- 8 other devices also cite its predicate K112453.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
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.
https://510kreport.com/device/K170528 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170528: 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/K170528
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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