510(k) · Cleared
ClearedShurFit Lumbar Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Spine, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Dec 8, 2021 as substantially equivalent to K171657 (Precision Spine, Inc., 2017) and 8 other predicates after a 159-day review. Its family tree reaches back 22 generations to 1984. 1 of the 395 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Dec 8, 2021
- Review
- 159 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 22 generations to K841189 (1984). 393 ancestors in all, the oldest K792352 (1979). 1 later device descends from it, 1 citing it directly. 1 of the 395 devices in this family, counting this one, has a Class I recall.
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations between
- 3 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 2 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 1 generation backK172341 NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017
- This deviceK212075 ShurFit Lumbar Interbody SystemPrecision Spine, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK221172 FOCUS Interbody SystemOc Medical Devices · 2022
Show all 22 generations
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 20 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 19 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 16 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 15 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 12 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 11 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 10 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 9 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 8 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 7 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 6 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 5 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 4 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 3 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 2 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 1 generation backK172341 NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017
- This deviceK212075 ShurFit Lumbar Interbody SystemPrecision Spine, Inc. · 2021
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K221172FOCUS Interbody SystemOc Medical Devices · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −21 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −20 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −19 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −16 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −15 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −12 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −11 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −10 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −9 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −8 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −7 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −6 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −5 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −4 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −3 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −2 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −1 | K172341 | NuVasive® Modulus TLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| 0 (this device) | K212075 | ShurFit Lumbar Interbody System | Precision Spine, Inc. | 2021 | — |
| +1 | K221172 | FOCUS Interbody System | Oc Medical Devices | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 6 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 12 | 0 |
| 2002 | 11 | 0 |
| 2003 | 19 | 0 |
| 2004 | 28 | 0 |
| 2005 | 21 | 0 |
| 2006 | 11 | 0 |
| 2007 | 18 | 0 |
| 2008 | 48 | 1 |
| 2009 | 36 | 0 |
| 2010 | 25 | 0 |
| 2011 | 30 | 0 |
| 2012 | 19 | 0 |
| 2013 | 18 | 0 |
| 2014 | 21 | 0 |
| 2015 | 16 | 0 |
| 2016 | 7 | 0 |
| 2017 | 6 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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.
1 device in this family has a Class I recall. 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? (9)
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 |
|---|---|---|---|
| * | K171657 | ShurFit 2C Lumbar Interbody Fusion SystemSummary page 5…Proprietary or Manufacturer Product Code Predicate Model Name Type K171657 ShurFit 2C Lumbar Precision Spine, Inc. MAX Primary Interbody Fusion… | 2017 |
| * | K092193 | Spinal Usa Interbody CagesSummary page 5…Type K171657 ShurFit 2C Lumbar Precision Spine, Inc. MAX Primary Interbody Fusion System K092193, K081196, Spinal USA Intervertebral Spinal USA (now Precision MAX Additional K080314 Body Fusion De… | 2009 |
| * | K081196 | Spinal Usa VBR SystemSummary page 5…Type K171657 ShurFit 2C Lumbar Precision Spine, Inc. MAX Primary Interbody Fusion System K092193, K081196, Spinal USA Intervertebral Spinal USA (now Precision MAX Additional K080314 Body Fusion Device… | 2008 |
| * | K080314 | Spinal Usa Interbody Fusion DeviceSummary page 5…X Primary Interbody Fusion System K092193, K081196, Spinal USA Intervertebral Spinal USA (now Precision MAX Additional K080314 Body Fusion Device Spine, Inc.) K172341 NuVasive® Modulus TLIF NuVasive, Inc.… | 2008 |
| * | K172341 | NuVasive® Modulus TLIF Interbody SystemSummary page 5…tem K092193, K081196, Spinal USA Intervertebral Spinal USA (now Precision MAX Additional K080314 Body Fusion Device Spine, Inc.) K172341 NuVasive® Modulus TLIF NuVasive, Inc. MAX Additional Interbody Syst… | 2017 |
| * | K181589 | Curiteva Lumbar Interbody Fusion SystemSummary page 5…evice Spine, Inc.) K172341 NuVasive® Modulus TLIF NuVasive, Inc. MAX Additional Interbody System K181589 Curiteva Lumbar Interbody Curiteva, LLC MAX Additional System K16249… | 2018 |
| * | K162496 | Foundation 3D InterbodySummary page 5…Interbody System K181589 Curiteva Lumbar Interbody Curiteva, LLC MAX Additional System K162496 Foundation™ 3D Interbody CoreLink, LLC MAX Additional K180963 ROCCIA TLIF… | 2017 |
| * | K180963 | Roccia Alif, Roccia TlifSummary page 5…MAX Additional System K162496 Foundation™ 3D Interbody CoreLink, LLC MAX Additional K180963 ROCCIA TLIF Silony Medical GmbH MAX, PHM Additional K201024 Expandable Tit… | 2018 |
| * | K201024 | Expandable Titanium PLIF/TLIF SystemSummary page 5…nterbody CoreLink, LLC MAX Additional K180963 ROCCIA TLIF Silony Medical GmbH MAX, PHM Additional K201024 Expandable Titanium Spectrum Spine, LLC MAX Additional PLIF/TLIF Syst… | 2021 |
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 |
|---|---|---|---|
| K221172 | FOCUS Interbody System | 2022 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 37 years and passes through 13 companies; a new generation was cleared every 10 months on median.
- 51 of the 393 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K221172 (Oc Medical Devices, 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K171657.
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. 2021, 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 ShurFit Lumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space for the ALIF, LLIF, TLIF and T-PLIF system. Two devices are used per intervertebral space for the PLIF system. The ShurFit Lumbar Interbody System (ALIF, LLIF, TLIF, T-PLIF and PLIF Systems) is intended for use at…
Read the full statement (154 words)
The ShurFit Lumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space for the ALIF, LLIF, TLIF and T-PLIF system. Two devices are used per intervertebral space for the PLIF system.
The ShurFit Lumbar Interbody System (ALIF, LLIF, TLIF, T-PLIF and PLIF Systems) is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with supplemental fixation and autogenous autograft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212075 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212075: ShurFit Lumbar Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212075
Report an extraction error
Are you the manufacturer?
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