510(k) · Cleared
Recalled · Class II · 2017Syzygy Stabilization 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 Apr 27, 2016 as substantially equivalent to K072116 (Neurospine Innovations and Solutions, 2008) and 3 other predicates after a 177-day review. Its family tree reaches back 6 generations to 1996. It has been recalled 2 times.
- Decided
- Apr 27, 2016
- Review
- 177 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 6 generations to K955348 (1996). 27 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 deviceK153152 Syzygy Stabilization 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) | K153152 | Syzygy Stabilization 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 | 2 | 0 |
| 2000 | 7 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 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? (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 |
|---|---|---|---|
| * | K072116 | Savannah Lumbar Percutaneous Stabilization SystemSummary page 4…MNH, Class II, Spondylolisthesis Spinal Fixation Device System Primary Predicate: Savannah Lumbar Percutaneous Stabilization System (K072116) Additional Predicate: Savannah-T Pedicle Screw System (K132925) Pangea (K052123)… | 2008 |
| * | K132925 | Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial Mid-Top, Savannah-T…Summary page 4…Device System Primary Predicate: Savannah Lumbar Percutaneous Stabilization System (K072116) Additional Predicate: Savannah-T Pedicle Screw System (K132925) Pangea (K052123) Talon Spinal System (K102995) Device Description:… | 2014 |
| * | K052123 | Synthes Pangea SystemSummary page 4…avannah Lumbar Percutaneous Stabilization System (K072116) Additional Predicate: Savannah-T Pedicle Screw System (K132925) Pangea (K052123) Talon Spinal System (K102995) Device Description: The Syzygy Stabilization System consists of pos… | 2005 |
| * | K102995 | Talon Spinal SystemSummary page 4…Additional Predicate: Savannah-T Pedicle Screw System (K132925) Pangea (K052123) Talon Spinal System (K102995) Device Description: The Syzygy Stabilization System consists of posted screws, couplers, and associated surgical instruments. T… | 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 |
|---|---|---|---|---|
| Jul 7, 2017 | Class II | Z-0325-2018 | Process control | Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length. |
| 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.
- 4 of the 27 ancestors have a recall of any class.
- 1 other device also cites its predicate K072116.
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 Syzygy Stabilization 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 Syzygy Stabilization System is indicated for one or more of…
Read the full statement (187 words)
The Syzygy Stabilization 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 Syzygy Stabilization System 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 Syzygy Stabilization System 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 as stated in the FDA summary.
https://510kreport.com/device/K153152 · printed Nov 3, 2026
Cite this page
510(k) Report. “K153152: Syzygy Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K153152
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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