510(k) · Cleared
ClearedSavannah Lumbar Percutaneous Stabilization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurospine Innovations and Solutions · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Mar 20, 2008 as substantially equivalent to K022949 (Synthes (Usa), 2003) and 13 other predicates after a 232-day review. Its family tree reaches back 4 generations to 1996. 24 later devices descend from it.
- Decided
- Mar 20, 2008
- Review
- 232 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 14
Its longest line of descent runs back 4 generations to K955348 (1996). 19 ancestors in all, the oldest K933881 (1994). 24 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK955348 Titanium Moss Miami Spinal SystemDepuy, Inc. · 1996
- 3 generations backK964024 Depuy Motech Titanium Moss Miami Spinal SystemDepuy, Inc. · 1997
- 2 generations backK992168 Moss Miami 6.35MM Polyaxial ScrewDepuyacromed · 1999
- 1 generation backK022623 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Depuyacromed · 2002
- This deviceK072116 Savannah Lumbar Percutaneous Stabilization SystemNeurospine Innovations and Solutions · 2008
- Descendant · cites it directly · 23 of its ownK132925 Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial…Amendia, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 13 of its ownK192121 Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019
- Descendant · 3 generations on · 12 of its ownK213935 PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022
- Descendant · 2 generations on · 6 of its ownK161842 Overwatch Spine SystemAmendia, Inc. · 2016 · Recalled
- Descendant · 4 generations on · 5 of its ownK231199 Solar Lumbar Interbody Fusion SystemDegen Medical · 2023
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K132925Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial Mid-Top, Savannah-T…Amendia, Inc. · 2014 · cites it directly23descendants
- K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019 · 2 generations on13descendants
- K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022 · 3 generations on12descendants
- K161842Overwatch Spine SystemAmendia, Inc. · 2016 · 2 generations on6descendants
- K231199Solar Lumbar Interbody Fusion SystemDegen Medical · 2023 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K955348 | Titanium Moss Miami Spinal System | Depuy, Inc. | 1996 | — |
| −3 | K964024 | Depuy Motech Titanium Moss Miami Spinal System | Depuy, Inc. | 1997 | — |
| −2 | K992168 | Moss Miami 6.35MM Polyaxial Screw | Depuyacromed | 1999 | — |
| −1 | K022623 | 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System) | Depuyacromed | 2002 | — |
| 0 (this device) | 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 |
| +2 | K192121 | Black Diamond Pedicle Screw System | Osseus Fusion Systems | 2019 | — |
| +3 | K213935 | PISCES-SA Standalone ALIF Interbody System | Osseus Fusion Systems | 2022 | — |
| +2 | K161842 | Overwatch Spine System | Amendia, Inc. | 2016 | 1 |
| +4 | K231199 | Solar Lumbar Interbody Fusion System | Degen Medical | 2023 | — |
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 | 5 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 7 | 0 |
| 2026 | 2 | 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? (14)
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 |
|---|---|---|---|
| * | K022949 | Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature UssSummary page 2…equivalent to previously cleared devices and has the same indications for use, design, function, and materials used. These include the Synthes USS Pedicle Screw System (K022949, K010108, K010658, K994121, and K982987), DePuy Moss Miami Spinal System (K022623, K983583, K964024, K955348, and K933881), the U… | 2003 |
| * | K010108 | Uss-Line ExtensionSummary page 2…nt to previously cleared devices and has the same indications for use, design, function, and materials used. These include the Synthes USS Pedicle Screw System (K022949, K010108, K010658, K994121, and K982987), DePuy Moss Miami Spinal System (K022623, K983583, K964024, K955348, and K933881), the U&I Optima… | 2001 |
| * | K010658 | Modified Uss Fracture SystemSummary page 2…viously cleared devices and has the same indications for use, design, function, and materials used. These include the Synthes USS Pedicle Screw System (K022949, K010108, K010658, K994121, and K982987), DePuy Moss Miami Spinal System (K022623, K983583, K964024, K955348, and K933881), the U&I Optima Spinal S… | 2001 |
| * | K994121 | Small Stature UssSummary page 2…leared devices and has the same indications for use, design, function, and materials used. These include the Synthes USS Pedicle Screw System (K022949, K010108, K010658, K994121, and K982987), DePuy Moss Miami Spinal System (K022623, K983583, K964024, K955348, and K933881), the U&I Optima Spinal System (K0… | 2000 |
| * | K982987 | Synthes Posterior Universal Spinal SystemSummary page 2…s and has the same indications for use, design, function, and materials used. These include the Synthes USS Pedicle Screw System (K022949, K010108, K010658, K994121, and K982987), DePuy Moss Miami Spinal System (K022623, K983583, K964024, K955348, and K933881), the U&I Optima Spinal System (K031585) and th… | 1998 |
| * | K022623 | 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Summary page 2…sign, function, and materials used. These include the Synthes USS Pedicle Screw System (K022949, K010108, K010658, K994121, and K982987), DePuy Moss Miami Spinal System (K022623, K983583, K964024, K955348, and K933881), the U&I Optima Spinal System (K031585) and the Stryker Spine Xia Spinal System (KO01319… | 2002 |
| * | K983583 | Depuy Acromed Moss and Moss Miami Spinal SystemsSummary page 2…ction, and materials used. These include the Synthes USS Pedicle Screw System (K022949, K010108, K010658, K994121, and K982987), DePuy Moss Miami Spinal System (K022623, K983583, K964024, K955348, and K933881), the U&I Optima Spinal System (K031585) and the Stryker Spine Xia Spinal System (KO01319, K984251… | 1998 |
| * | K964024 | Depuy Motech Titanium Moss Miami Spinal SystemSummary page 2…d materials used. These include the Synthes USS Pedicle Screw System (K022949, K010108, K010658, K994121, and K982987), DePuy Moss Miami Spinal System (K022623, K983583, K964024, K955348, and K933881), the U&I Optima Spinal System (K031585) and the Stryker Spine Xia Spinal System (KO01319, K984251, and K95… | 1997 |
| * | K955348 | Titanium Moss Miami Spinal SystemSummary page 2…ls used. These include the Synthes USS Pedicle Screw System (K022949, K010108, K010658, K994121, and K982987), DePuy Moss Miami Spinal System (K022623, K983583, K964024, K955348, and K933881), the U&I Optima Spinal System (K031585) and the Stryker Spine Xia Spinal System (KO01319, K984251, and K951725). P… | 1996 |
| * | K933881 | Depuy Motech Moss-Miami Spinal SystemSummary page 2…e include the Synthes USS Pedicle Screw System (K022949, K010108, K010658, K994121, and K982987), DePuy Moss Miami Spinal System (K022623, K983583, K964024, K955348, and K933881), the U&I Optima Spinal System (K031585) and the Stryker Spine Xia Spinal System (KO01319, K984251, and K951725). Performance Te… | 1994 |
| * | K031585 | U&I, Optima, Spinal SystemSummary page 2…System (K022949, K010108, K010658, K994121, and K982987), DePuy Moss Miami Spinal System (K022623, K983583, K964024, K955348, and K933881), the U&I Optima Spinal System (K031585) and the Stryker Spine Xia Spinal System (KO01319, K984251, and K951725). Performance Testing: The pre-clinical testing perform… | 2003 |
| * | K001319 | Xia Spine System Hooks | 2000 |
| * | K984251 | Xia Spine SystemSummary page 2…ePuy Moss Miami Spinal System (K022623, K983583, K964024, K955348, and K933881), the U&I Optima Spinal System (K031585) and the Stryker Spine Xia Spinal System (KO01319, K984251, and K951725). Performance Testing: The pre-clinical testing performed indicated that the Savannah Lumbar Percutaneous Stabiliz… | 1999 |
| * | K951725 | Osteonics Spinal SystemSummary page 2…mi Spinal System (K022623, K983583, K964024, K955348, and K933881), the U&I Optima Spinal System (K031585) and the Stryker Spine Xia Spinal System (KO01319, K984251, and K951725). Performance Testing: The pre-clinical testing performed indicated that the Savannah Lumbar Percutaneous Stabilization System… | 1995 |
What descends from it? (24)
See all 242 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 19 ancestors have a recall of any class.
- Of its descendants, K132925 (Amendia, Inc., 2014) has gone furthest, with 23 descendants of its own.
- 20 other devices also cite its predicate K022949.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Lumbar Percutaneous Stabilization System (SLPSS) is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows: When used as a pedicle screw fixation system of the posterior lumbar spine in skeletally mature patients, the SLPSS is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of…
Read the full statement (221 words)
The Savannah Lumbar Percutaneous Stabilization System (SLPSS) is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:
When used as a pedicle screw fixation system of the posterior lumbar spine in skeletally mature patients, the SLPSS is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) spinal tumor, and/or (5) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the SLPSS is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S 1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.
The Savannah Lumbar Percutaneous Stabilization System (SLPSS) is also intended to provide immobilization and stabilization of the spinal segments of the lumbar and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S I or degenerative spondylolisthesis with objective evidence of neurologic impairment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072116 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072116: Savannah Lumbar Percutaneous Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072116
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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