510(k) · Cleared
ClearedT-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes USA Products, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Nov 1, 2016 as substantially equivalent to K150673 (Synthes (USA) Products, LLC, 2015) and 4 other predicates after a 70-day review. Its family tree reaches back 18 generations to 1984. 127 later devices descend from it.
- Decided
- Nov 1, 2016
- Review
- 70 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 18 generations to K841189 (1984). 239 ancestors in all. 127 later devices descend from it, 5 citing it directly.
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations between
- 3 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 2 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 1 generation backK151773 CONCORDE Bullet Lumbar Interbody SystemMedos International SARL · 2015
- This deviceK162358 T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution…Synthes USA Products, LLC · 2016
- Descendant · cites it directly · 109 of its ownK171689 ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti…Medtronic Sofamor Danek USA, Inc. · 2017
- Descendant · 2 generations on · 108 of its ownK190959 ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti…Medtronic Sofamor Danek USA, Inc. · 2019
- Descendant · 3 generations on · 102 of its ownK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- Descendant · 4 generations on · 81 of its ownK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
- Descendant · 2 generations on · 79 of its ownK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
Show all 18 generations
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 16 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 15 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 12 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 11 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 8 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 7 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 6 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 5 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 4 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 3 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 2 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 1 generation backK151773 CONCORDE Bullet Lumbar Interbody SystemMedos International SARL · 2015
- This deviceK162358 T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution…Synthes USA Products, LLC · 2016
Showing 5 of 127 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 127 · See all- K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc. · 2017 · cites it directly109descendants
- K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc. · 2019 · 2 generations on108descendants
- K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc. · 2019 · 3 generations on102descendants
- K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc. · 2020 · 4 generations on81descendants
- K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020 · 2 generations on79descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −17 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −16 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −15 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −12 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −11 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −8 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −7 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −6 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −5 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −4 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −3 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −2 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −1 | K151773 | CONCORDE Bullet Lumbar Interbody System | Medos International SARL | 2015 | — |
| 0 (this device) | K162358 | T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System | Synthes USA Products, LLC | 2016 | — |
| +1 | K171689 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal… | Medtronic Sofamor Danek USA, Inc. | 2017 | — |
| +2 | K190959 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal… | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| +3 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| +4 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic… | Titan Spine, Inc. | 2020 | — |
| +2 | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 10 | 0 |
| 2002 | 9 | 0 |
| 2003 | 15 | 0 |
| 2004 | 22 | 0 |
| 2005 | 15 | 0 |
| 2006 | 8 | 0 |
| 2007 | 12 | 0 |
| 2008 | 34 | 0 |
| 2009 | 18 | 0 |
| 2010 | 17 | 0 |
| 2011 | 16 | 0 |
| 2012 | 10 | 0 |
| 2013 | 11 | 0 |
| 2014 | 11 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 5 | 0 |
| 2021 | 8 | 0 |
| 2022 | 15 | 0 |
| 2023 | 14 | 0 |
| 2024 | 28 | 0 |
| 2025 | 25 | 0 |
| 2026 | 26 | 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 MAX? 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K150673 | SYNFIX Evolution Secured Spacer SystemSummary page 6…vice, 21 CFR 888.3080 Name SYNFIX Evolution System - Intervertebral Body Fusion Device, 21 CFR 888.3080 Primary SYNFIX Evolution System – K150673 Predicate DePuy Spine Concorde Bullet System - K151773 Additional NuVasive Interfixated Interbody System… | 2015 |
| * | K151773 | CONCORDE Bullet Lumbar Interbody SystemSummary page 6…tebral Body Fusion Device, 21 CFR 888.3080 Primary SYNFIX Evolution System – K150673 Predicate DePuy Spine Concorde Bullet System - K151773 Additional NuVasive Interfixated Interbody System - K160051 Predicate T-PAL Spacer System - K100089… | 2015 |
| * | K160051 | NuVasive® Interfixated Interbody SystemSummary page 6…SYNFIX Evolution System – K150673 Predicate DePuy Spine Concorde Bullet System - K151773 Additional NuVasive Interfixated Interbody System - K160051 Predicate T-PAL Spacer System - K100089 T-PAL Titanium Spacer System - K151276 K162358 Pa… | 2016 |
| * | K100089 | Synthes T-Pal SpacerSummary page 6…e DePuy Spine Concorde Bullet System - K151773 Additional NuVasive Interfixated Interbody System - K160051 Predicate T-PAL Spacer System - K100089 T-PAL Titanium Spacer System - K151276 K162358 Page 2 of 3 Device Description 7 3%/ DQG7 3%/ 7… | 2010 |
| * | K151276 | DePuy Synthes T-PAL Ti SpacerSummary page 6…K151773 Additional NuVasive Interfixated Interbody System - K160051 Predicate T-PAL Spacer System - K100089 T-PAL Titanium Spacer System - K151276 K162358 Page 2 of 3 Device Description 7 3%/ DQG7 3%/ 7DMIXP 6SI[FHIG\ VWP 7KH7 3%/ 6 SIFHUIVDWHRXFHMWOQMERG X… | 2015 |
What descends from it? (127)
See all 1275 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171689 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with… | 2017 | 109 |
| K212498 | Stable-L Standalone Lumbar Interbody System | 2022 | 7 |
| K180590 | Tyber Medical PT Interbody Spacer System | 2018 | 6 |
| K223688 | CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ Instruments | 2023 | 0 |
| K213653 | 4CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage System | 2022 | 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 32 years and passes through 13 companies; a new generation was cleared every 11 months on median.
- 26 of the 239 ancestors have a recall of any class.
- Of its descendants, K171689 (Medtronic Sofamor Danek USA, Inc., 2017) has gone furthest, with 109 descendants of its own.
- 4 other devices also cite its predicate K150673.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The T-PAL Spacer System is indicated for use as an intervertebral body fusion device in skeletally mature patients with radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the T-PAL Spacer System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six months of non-operative treatment prior to surgery. These implants…
Read the full statement (394 words)
The T-PAL Spacer System is indicated for use as an intervertebral body fusion device in skeletally mature patients with radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the T-PAL Spacer System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device these implants are intended for
The T-PAL Titanium Spacer System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the T-PAL Titanium Spacer System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device these implants are intended for
The SYNFIX Evolution Spacer System is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have had six months of non-operative treatment.
Additionally, the SYNFIX Evolution Spacer can be used in patients diagnosed with spinal deformities as an adjunct to fusion with DePuy Synthes Spine supplemental internal fixation products (e.g. pedicle screw system) for use in the lumbar spine in addition to integrated screws. These patients should be skeletally mature and have undergone six months of nonoperative treatment prior to surgery.
These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
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/K162358 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162358: T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162358
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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