510(k) · Cleared
ClearedR&D Innovation Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
R&D Innovation, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on May 18, 2012 as substantially equivalent to K071824 (Acme Spine, LLC, 2007) and 2 other predicates after a 128-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- May 18, 2012
- Review
- 128 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K955348 (1996). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK955348 Titanium Moss Miami Spinal SystemDepuy, Inc. · 1996
- 1 generation backK103490 Expedium Spine System, Moss Miami Spine SystemJohnson & Johnson · 2011
- This deviceK120091 R&D Innovation Pedicle Screw SystemR&D Innovation, LLC · 2012
- Descendant · cites it directly · 0 of its ownK180655 Viking Lumbar Polyaxial Screw SystemPresidio Surgical · 2018
Most influential descendants
Showing 1 of 1 · See all- K180655Viking Lumbar Polyaxial Screw SystemPresidio Surgical · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955348 | Titanium Moss Miami Spinal System | Depuy, Inc. | 1996 | — |
| −1 | K103490 | Expedium Spine System, Moss Miami Spine System | Johnson & Johnson | 2011 | — |
| 0 (this device) | K120091 | R&D Innovation Pedicle Screw System | R&D Innovation, LLC | 2012 | — |
| +1 | K180655 | Viking Lumbar Polyaxial Screw System | Presidio Surgical | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (3)
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 |
|---|---|---|---|
| * | K071824 | Acme Talon Pedicle ScrewSummary page 1…habilitation Devices Panel Predicate Devices: Device Names: ACME Spinal System, 510(K) Number: K071824 Moss Miami and Expedium Spinal System, 510(K) Number:… | 2007 |
| * | K103490 | Expedium Spine System, Moss Miami Spine SystemSummary page 1…10(K) Number: K071824 Moss Miami and Expedium Spinal System, 510(K) Number: K103490 & K(955348 DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The R&D Innovation Pedicle Screw System is a… | 2011 |
| * | K955348 | Titanium Moss Miami Spinal SystemSummary page 2…devices which are the ACME Spinal System, now marketed a Spine 360 Talon Pedlicle Screw System, (K(071824) and DePuy Moss Miami and Expedium (K(103490 & K955348). The R&D Innovation pedicle screw system and the predicate devices have similar indication for use and methods of operat… | 1996 |
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 |
|---|---|---|---|
| K180655 | Viking Lumbar Polyaxial Screw System | 2018 | 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 16 years and passes through 3 companies; a new generation was cleared every 15.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K180655 (Presidio Surgical, 2018) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K071824.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
When used as a pedicle screw fixation system in the non-cervical posterior spine (Ti-Si) in skeletally mature patients, the R&D Innovation 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 and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: (1) degenerative disc disease (defined as back…
Read the full statement (124 words)
When used as a pedicle screw fixation system in the non-cervical posterior spine (Ti-Si) in skeletally mature patients, the R&D Innovation 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 and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) curvatures (i.e., scoliosis, kyphosis, and/or lordosis, (7) tumor, (8) failed previous fusion (i.e. pseudarthrosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120091 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120091: R&D Innovation 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/K120091
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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