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 Nov 20, 2015 as substantially equivalent to K133369 (Corelink, LLC, 2014) and 3 other predicates after a 143-day review. Its family tree reaches back 16 generations to 1985. 1 later device descends from it.
- Decided
- Nov 20, 2015
- Review
- 143 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 16 generations to K853033 (1985). 290 ancestors in all, the oldest K841189 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 16 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 12 generations between
- 3 generations backK120696 Tiger Spine SystemCorelink, LLC · 2012
- 2 generations backK131250 Tiger Spine SystemCorelink, LLC · 2013
- 1 generation backK133369 Tiger Spine SystemCorelink, LLC · 2014
- This deviceK151770 Libra Pedicle Screw SystemSpinal Balance, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK162750 Libra Pedicle Screw SystemSpinal Balance, Inc. · 2016
Show all 16 generations
- Root · 16 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 15 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 14 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 13 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 12 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 11 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 10 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 9 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 8 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 7 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 6 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 5 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 4 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 3 generations backK120696 Tiger Spine SystemCorelink, LLC · 2012
- 2 generations backK131250 Tiger Spine SystemCorelink, LLC · 2013
- 1 generation backK133369 Tiger Spine SystemCorelink, LLC · 2014
- This deviceK151770 Libra Pedicle Screw SystemSpinal Balance, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K162750Libra Pedicle Screw SystemSpinal Balance, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −15 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −14 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −13 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −12 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −11 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −10 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −9 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −8 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −7 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −6 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −5 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −4 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −3 | K120696 | Tiger Spine System | Corelink, LLC | 2012 | — |
| −2 | K131250 | Tiger Spine System | Corelink, LLC | 2013 | — |
| −1 | K133369 | Tiger Spine System | Corelink, LLC | 2014 | — |
| 0 (this device) | K151770 | Libra Pedicle Screw System | Spinal Balance, Inc. | 2015 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (4)
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 |
|---|---|---|---|
| * | K133369 | Tiger Spine SystemSummary page 5…components are manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F136) Predicate Devices: Primary: Tiger® Spine System (Corelink, LLC – K133369) Additional: CD Horizon® Spinal System (Medtronic Sofamor Danek – K143569), Rad… | 2014 |
| * | K143569 | CD HORIZON Spinal SystemSummary page 5…Primary: Tiger® Spine System (Corelink, LLC – K133369) Additional: CD Horizon® Spinal System (Medtronic Sofamor Danek – K143569), Radius® Spinal System (Stryker Spine – K101144) and Foundation Spinal System (Skeletal Design Partners… | 2015 |
| * | K101144 | Modification to:Radius Spinal SystemSummary page 5…3369) Additional: CD Horizon® Spinal System (Medtronic Sofamor Danek – K143569), Radius® Spinal System (Stryker Spine – K101144) and Foundation Spinal System (Skeletal Design Partnership – K120074) Reference Devices: Moss Miam… | 2010 |
| * | K120074 | Foundation Spinal SystemSummary page 5…– K143569), Radius® Spinal System (Stryker Spine – K101144) and Foundation Spinal System (Skeletal Design Partnership – K120074) Reference Devices: Moss Miami™ Spinal System (DePuy AcroMed, Inc. – K022623), Optima™ Spinal Syst… | 2012 |
| † | K022623 | 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System) | 2002 |
| † | K051971 | Optima Spinal System | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162750 | Libra Pedicle Screw System | 2016 | 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 30 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 20 of the 290 ancestors have a recall of any class.
- Of its descendants, K162750 (Spinal Balance, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K133369.
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 Libra Pedicle Screw System is intended for immobilization and stabilization of the posterior thoracic, lumbar and sacral/iliac spine (Tl-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/K151770 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151770: 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/K151770
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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