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 Oct 8, 2015 as substantially equivalent to K011437 (Interpore Cross Intl., 2001) and 1 other predicate after an 87-day review. Its family tree reaches back 6 generations to 1992. 3 later devices descend from it.
- Decided
- Oct 8, 2015
- Review
- 87 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K921873 (1992). 15 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK921873 Quickanchor, ModificationMitek Surgical Products, Inc. · 1992
- 5 generations backK992487 Mitek Mini Quickanchor PlusMitek Products · 1999
- 4 generations backK061349 Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006
- 3 generations backK090615 Opus Speedlock Knotless Fixation DeviceArthrocare Corp. · 2009 · Recalled
- 2 generations backK101437 Speedfix Suture SystemArthrocare Corp. · 2010
- 1 generation backK112453 Sterispineps Pedicle ScrewSafe Orthopaedics · 2011
- This deviceK151921 Sterispine PSSafe Orthopaedics · 2015
- Descendant · cites it directly · 2 of its ownK170528 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
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921873 | Quickanchor, Modification | Mitek Surgical Products, Inc. | 1992 | — |
| −5 | K992487 | Mitek Mini Quickanchor Plus | Mitek Products | 1999 | — |
| −4 | K061349 | Opus Labralock P Knotless Fixation Device | Arthrocare Corp. | 2006 | — |
| −3 | K090615 | Opus Speedlock Knotless Fixation Device | Arthrocare Corp. | 2009 | 1 |
| −2 | K101437 | Speedfix Suture System | Arthrocare Corp. | 2010 | — |
| −1 | K112453 | Sterispineps Pedicle Screw | Safe Orthopaedics | 2011 | — |
| 0 (this device) | K151921 | Sterispine PS | Safe Orthopaedics | 2015 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K011437 | Synergy 4.0 MM, 4.5 MM VLS ScrewsSummary page 4…III Product Code NKB, MNI, MNH, KWP CFR section 888.3070 Device panel Orthopedic Primary predicate device: Synergy VLS (K011437) manufactured by Legally marketed Interpore Cross International. predicate devices Other predicate device: STERISPINE™ PS ma… | 2001 |
| * | K112453 | Sterispineps Pedicle ScrewSummary page 4…d by Legally marketed Interpore Cross International. predicate devices Other predicate device: STERISPINE™ PS manufactured by SAFE ORTHOPAEDICS (K112453) The SteriSpine™PS system is intended to provide immobilization and stabilization of spin… | 2011 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 3 of the 15 ancestors have a recall of any class.
- Of its descendants, K170528 (Safe Orthopaedics, 2017) has gone furthest, with 2 descendants of its own.
- 11 other devices also cite its predicate K011437.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 (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/K151921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151921: 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/K151921
Report an extraction error
Are you the manufacturer?
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