510(k) · Cleared
ClearedLibra Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Balance, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Oct 27, 2016 as substantially equivalent to K151770 (Spinal Balance, Inc., 2015) after a 27-day review. Its family tree reaches back 17 generations to 1985.
- Decided
- Oct 27, 2016
- Review
- 27 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K853033 (1985). 291 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.
- Root · 17 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 13 generations between
- 3 generations backK131250 Tiger Spine SystemCorelink, LLC · 2013
- 2 generations backK133369 Tiger Spine SystemCorelink, LLC · 2014
- 1 generation backK151770 Libra Pedicle Screw SystemSpinal Balance, Inc. · 2015
- This deviceK162750 Libra Pedicle Screw SystemSpinal Balance, Inc. · 2016
Show all 17 generations
- Root · 17 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 16 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 15 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 14 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 13 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 12 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 11 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 10 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 9 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 8 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 7 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 6 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 5 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 4 generations backK120696 Tiger Spine SystemCorelink, LLC · 2012
- 3 generations backK131250 Tiger Spine SystemCorelink, LLC · 2013
- 2 generations backK133369 Tiger Spine SystemCorelink, LLC · 2014
- 1 generation backK151770 Libra Pedicle Screw SystemSpinal Balance, Inc. · 2015
- This deviceK162750 Libra Pedicle Screw SystemSpinal Balance, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −16 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −15 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −14 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −13 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −12 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −11 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −10 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −9 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −8 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −7 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −6 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −5 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −4 | K120696 | Tiger Spine System | Corelink, LLC | 2012 | — |
| −3 | K131250 | Tiger Spine System | Corelink, LLC | 2013 | — |
| −2 | K133369 | Tiger Spine System | Corelink, LLC | 2014 | — |
| −1 | K151770 | Libra Pedicle Screw System | Spinal Balance, Inc. | 2015 | — |
| 0 (this device) | K162750 | Libra Pedicle Screw System | Spinal Balance, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 4 | 0 |
| 1994 | 3 | 0 |
| 1995 | 8 | 0 |
| 1996 | 7 | 0 |
| 1997 | 8 | 0 |
| 1998 | 13 | 0 |
| 1999 | 16 | 0 |
| 2000 | 22 | 0 |
| 2001 | 22 | 0 |
| 2002 | 14 | 0 |
| 2003 | 14 | 0 |
| 2004 | 30 | 0 |
| 2005 | 25 | 0 |
| 2006 | 16 | 0 |
| 2007 | 12 | 0 |
| 2008 | 10 | 0 |
| 2009 | 11 | 0 |
| 2010 | 16 | 0 |
| 2011 | 6 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K151770 | Libra Pedicle Screw SystemSummary page 5…additionally manufactured from cobalt chrome (ASTM F1537). Predicate Device: Primary: Libra Pedicle Screw System (Spinal Balance, Inc. – K151770) Performance Data: Theoretical analysis of the proposed device modification was performed. The re… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 20 of the 291 ancestors have a recall of any class.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Libra Pedicle Screw System is intended for immobilization and stabilization of the posterior thoracic, lumbar and sacral/iliac spine (T1-S1/Ilium) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (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, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162750 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162750: Libra Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162750
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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