510(k) · Cleared
ClearedPINE Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tdm Co., Ltd. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on May 19, 2022 as substantially equivalent to K061202 (Globus Medical, Inc., 2006) and 3 other predicates after a 107-day review. Its family tree reaches back 10 generations to 1999.
- Decided
- May 19, 2022
- Review
- 107 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K990745 (1999). 60 ancestors in all, the oldest K933881 (1994). No later device cites it as a predicate yet.
- Root · 10 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 6 generations between
- 3 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 2 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 1 generation backK173131 Rexious Spinal Fixation SystemHuvexel Co., Ltd. · 2017
- This deviceK220285 PINE Pedicle Screw SystemTdm Co., Ltd. · 2022
Show all 10 generations
- Root · 10 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 9 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 8 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 7 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 6 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 5 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 4 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 3 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 2 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 1 generation backK173131 Rexious Spinal Fixation SystemHuvexel Co., Ltd. · 2017
- This deviceK220285 PINE Pedicle Screw SystemTdm Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −9 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −8 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −7 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −6 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −5 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −4 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −3 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| −2 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| −1 | K173131 | Rexious Spinal Fixation System | Huvexel Co., Ltd. | 2017 | — |
| 0 (this device) | K220285 | PINE Pedicle Screw System | Tdm Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 8 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 7 | 0 |
| 2004 | 7 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K061202 | Revere Stabilization SystemSummary page 5…marketed predicate devices. Predicate Device: Primary predicate: Globus Medical – REVERE Stabilization System (K061202) Additional predicates: Huvexel – Rexious Spinal Fixation System (K111362… | 2006 |
| * | K111362 | Rexious Spinal Fixation SystemSummary page 5…Medical – REVERE Stabilization System (K061202) Additional predicates: Huvexel – Rexious Spinal Fixation System (K111362 and K173131) and CG Bio. Co. Ltd. - LumFix Spinal Fixation System (K16073… | 2011 |
| * | K173131 | Rexious Spinal Fixation SystemSummary page 5…(K061202) Additional predicates: Huvexel – Rexious Spinal Fixation System (K111362 and K173131) and CG Bio. Co. Ltd. - LumFix Spinal Fixation System (K160731). Reference Devices: K171808… | 2017 |
| * | K160731 | LumFix Spinal Fixation SytemSummary page 5…exel – Rexious Spinal Fixation System (K111362 and K173131) and CG Bio. Co. Ltd. - LumFix Spinal Fixation System (K160731). Reference Devices: K171808 & K190391 - TDM Small Locking Plate and Screw System Technological The PINE P… | 2016 |
| † | K171808 | TDM Plate and Screw System | 2018 |
| † | K190391 | TDM Plate and Screw Systems | 2019 |
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 23 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 8 of the 60 ancestors have a recall of any class.
- 29 other devices also cite its predicate K061202.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
PINE Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute or chronic spinal instabilities or deformities in the thoracic, lumbar, and sacral spine:
- Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
- Spondylolisthesis
- Trauma (i.e., fracture or dislocation)
- Spinal stenosis
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- Tumor
- Pseudoarthrosis
- Failed previous fusion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220285: PINE 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/K220285
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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