510(k) · Cleared
ClearedSterispineps Pedicle Screw
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 Nov 15, 2011 as substantially equivalent to K101437 (Arthrocare Corp., 2010) after an 82-day review. Its family tree reaches back 5 generations to 1992. 10 later devices descend from it.
- Decided
- Nov 15, 2011
- Review
- 82 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K921873 (1992). 13 ancestors in all. 10 later devices descend from it, 9 citing it directly.
- Root · 5 generations backK921873 Quickanchor, ModificationMitek Surgical Products, Inc. · 1992
- 4 generations backK992487 Mitek Mini Quickanchor PlusMitek Products · 1999
- 3 generations backK061349 Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006
- 2 generations backK090615 Opus Speedlock Knotless Fixation DeviceArthrocare Corp. · 2009 · Recalled
- 1 generation backK101437 Speedfix Suture SystemArthrocare Corp. · 2010
- This deviceK112453 Sterispineps Pedicle ScrewSafe Orthopaedics · 2011
- Descendant · cites it directly · 6 of its ownK121299 Sterispineps Pedicle Screw, Sterispineps RodSafe Orthopaedics · 2012
- Descendant · cites it directly · 5 of its ownK130632 Sterispine PS Pedicle ScrewSafe Orthopaedics · 2013
- Descendant · cites it directly · 4 of its ownK150092 STERISPINE PS Pedicle ScrewSafe Orthopaedics · 2015
- Descendant · cites it directly · 4 of its ownK140802 Sterispine PSSafe Orthopaedics · 2014
- Descendant · cites it directly · 3 of its ownK151921 Sterispine PSSafe Orthopaedics · 2015
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K121299Sterispineps Pedicle Screw, Sterispineps RodSafe Orthopaedics · 2012 · cites it directly6descendants
- K130632Sterispine PS Pedicle ScrewSafe Orthopaedics · 2013 · cites it directly5descendants
- K150092STERISPINE PS Pedicle ScrewSafe Orthopaedics · 2015 · cites it directly4descendants
- K140802Sterispine PSSafe Orthopaedics · 2014 · cites it directly4descendants
- K151921Sterispine PSSafe Orthopaedics · 2015 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921873 | Quickanchor, Modification | Mitek Surgical Products, Inc. | 1992 | — |
| −4 | K992487 | Mitek Mini Quickanchor Plus | Mitek Products | 1999 | — |
| −3 | K061349 | Opus Labralock P Knotless Fixation Device | Arthrocare Corp. | 2006 | — |
| −2 | K090615 | Opus Speedlock Knotless Fixation Device | Arthrocare Corp. | 2009 | 1 |
| −1 | K101437 | Speedfix Suture System | Arthrocare Corp. | 2010 | — |
| 0 (this device) | K112453 | Sterispineps Pedicle Screw | Safe Orthopaedics | 2011 | — |
| +1 | K121299 | Sterispineps Pedicle Screw, Sterispineps Rod | Safe Orthopaedics | 2012 | — |
| +1 | K130632 | Sterispine PS Pedicle Screw | Safe Orthopaedics | 2013 | — |
| +1 | K150092 | STERISPINE PS Pedicle Screw | Safe Orthopaedics | 2015 | — |
| +1 | K140802 | Sterispine PS | Safe Orthopaedics | 2014 | — |
| +1 | K151921 | Sterispine PS | Safe Orthopaedics | 2015 | — |
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 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K101437 | Speedfix Suture System | 2010 |
What descends from it? (10)
9 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121299 | Sterispineps Pedicle Screw, Sterispineps Rod | 2012 | 6 |
| K130632 | Sterispine PS Pedicle Screw | 2013 | 5 |
| K150092 | STERISPINE PS Pedicle Screw | 2015 | 4 |
| K140802 | Sterispine PS | 2014 | 4 |
| K151921 | Sterispine PS | 2015 | 3 |
| K151747 | Sterispine PS | 2015 | 3 |
| K170528 | Sterispine™ PS | 2017 | 2 |
| K201648 | Sterispine™ PS | 2020 | 1 |
| K171582 | NEO Pedicle Screw System™ | 2017 | 0 |
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 19 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K121299 (Safe Orthopaedics, 2012) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K101437.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 to fusion.
SteriSpine'"PS System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DOD) (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/K112453 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112453: Sterispineps Pedicle Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112453
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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