510(k) · Cleared
Recalled · Class II · 2016Savannah-T® Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amendia, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jul 8, 2016 as substantially equivalent to K132925 (Amendia, Inc., 2014) and 1 other predicate after a 280-day review. Its family tree reaches back 6 generations to 1996. It has been recalled once.
- Decided
- Jul 8, 2016
- Review
- 280 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K955348 (1996). 24 ancestors in all, the oldest K933881 (1994). No later device cites it as a predicate yet.
- Root · 6 generations backK955348 Titanium Moss Miami Spinal SystemDepuy, Inc. · 1996
- 5 generations backK964024 Depuy Motech Titanium Moss Miami Spinal SystemDepuy, Inc. · 1997
- 4 generations backK992168 Moss Miami 6.35MM Polyaxial ScrewDepuyacromed · 1999
- 3 generations backK022623 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Depuyacromed · 2002
- 2 generations backK072116 Savannah Lumbar Percutaneous Stabilization SystemNeurospine Innovations and Solutions · 2008
- 1 generation backK132925 Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial…Amendia, Inc. · 2014 · Recalled
- This deviceK152920 Savannah-T® Pedicle Screw SystemAmendia, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K955348 | Titanium Moss Miami Spinal System | Depuy, Inc. | 1996 | — |
| −5 | K964024 | Depuy Motech Titanium Moss Miami Spinal System | Depuy, Inc. | 1997 | — |
| −4 | K992168 | Moss Miami 6.35MM Polyaxial Screw | Depuyacromed | 1999 | — |
| −3 | K022623 | 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System) | Depuyacromed | 2002 | — |
| −2 | K072116 | Savannah Lumbar Percutaneous Stabilization System | Neurospine Innovations and Solutions | 2008 | — |
| −1 | K132925 | Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial Mid-Top… | Amendia, Inc. | 2014 | 1 |
| 0 (this device) | K152920 | Savannah-T® Pedicle Screw System | Amendia, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 6 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2007 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K132925 | Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial Mid-Top, Savannah-T…Summary page 4…NKB, Class III, Pedicle Screw Spinal System, For Degenerative Disc Disease Primary Predicate Device: Savannah-T® Pedicle Screw System (K132925) Additional Predicate: Talon Spinal System (K102995) Purpose of Submission: This special 510(k) is intended to gain cl… | 2014 |
| * | K102995 | Talon Spinal SystemSummary page 4…e Disc Disease Primary Predicate Device: Savannah-T® Pedicle Screw System (K132925) Additional Predicate: Talon Spinal System (K102995) Purpose of Submission: This special 510(k) is intended to gain clearance for addition of pre- contoured fixation rods to the Sa… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 22, 2016 | Class II | Z-0883-2017 | Employee error | The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 3 of the 24 ancestors have a recall of any class.
- 3 other devices also cite its predicate K132925.
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 Savannah-T® Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine, specifically as follows: * When intended for pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients the Savannah- T® is indicated for one or more of the…
Read the full statement (185 words)
The Savannah-T® Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments as an
adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar,
and/or sacral spine, specifically as follows:
* When intended for pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients the Savannah-
T® is indicated for one or more of the following: degenerative disc disease (defined as discogenic back pain with
degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; fracture; dislocation; scoliosis;
kyphosis; spinal tumor; and/or failed previous fusion (pseudarthrosis).
* In addition, when used as a pedicle screw fixation system, the Savannah-T® is indicated for skeletally mature patients
having degenerative spondylolisthesis with objective evidence of neurologic impairment and/or severe spondylolisthesis
(grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; who are receiving fusions using autogenous bone
graft only; who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and who are having
the device removed after the development of a solid fusion mass.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152920 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152920: Savannah-T® 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/K152920
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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