510(k) · Cleared
ClearedShurFit 2C Lumbar Interbody Fusion 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 Aug 11, 2017 as substantially equivalent to K092193 (Spinal USA, 2009) and 4 other predicates after a 67-day review. Its family tree reaches back 17 generations to 1984. 4 later devices descend from it.
- Decided
- Aug 11, 2017
- Review
- 67 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 17 generations to K841189 (1984). 208 ancestors in all, the oldest K792352 (1979). 4 later devices descend from it, 3 citing it directly.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK131429 Reliance Cervical Ibf SystemReliance Medical Systems, LLC · 2013
- 2 generations backK142269 Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2015
- 1 generation backK161809 ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. · 2016
- This deviceK171657 ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK212075 ShurFit Lumbar Interbody SystemPrecision Spine, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK221182 Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK221172 FOCUS Interbody SystemOc Medical Devices · 2022
- Descendant · cites it directly · 0 of its ownK212070 KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc. · 2021
Show all 17 generations
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 15 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 14 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 11 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 10 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 7 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 6 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 5 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 4 generations backK102547 Coroent Interlock SystemNuvasive, Inc. · 2011
- 3 generations backK131429 Reliance Cervical Ibf SystemReliance Medical Systems, LLC · 2013
- 2 generations backK142269 Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2015
- 1 generation backK161809 ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. · 2016
- This deviceK171657 ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc. · 2017
Most influential descendants
Showing 4 of 4 · See all- K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc. · 2021 · cites it directly1descendant
- K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd. · 2022 · cites it directly0descendants
- K221172FOCUS Interbody SystemOc Medical Devices · 2022 · 2 generations on0descendants
- K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −16 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −15 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −14 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −11 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −10 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −7 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −6 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −5 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −4 | K102547 | Coroent Interlock System | Nuvasive, Inc. | 2011 | — |
| −3 | K131429 | Reliance Cervical Ibf System | Reliance Medical Systems, LLC | 2013 | — |
| −2 | K142269 | Reliance Cervical IBF System | Reliance Medical Systems, LLC | 2015 | — |
| −1 | K161809 | ShurFit CpTi-HA ACIF Interbody Fusion System | Precision Spine, Inc. | 2016 | — |
| 0 (this device) | K171657 | ShurFit 2C Lumbar Interbody Fusion System | Precision Spine, Inc. | 2017 | — |
| +1 | K212075 | ShurFit Lumbar Interbody System | Precision Spine, Inc. | 2021 | — |
| +1 | K221182 | Southern Transforaminal Lumbar Interbody Fusion (TLIF) | Southern Medical (Pty), Ltd. | 2022 | — |
| +2 | K221172 | FOCUS Interbody System | Oc Medical Devices | 2022 | — |
| +1 | K212070 | KMTI S141 Lumbar Interbody Fusion System | Kyocera Medical Technologies, Inc. | 2021 | — |
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 | 2 | 0 |
| 2001 | 12 | 0 |
| 2002 | 10 | 0 |
| 2003 | 15 | 0 |
| 2004 | 26 | 0 |
| 2005 | 17 | 0 |
| 2006 | 9 | 0 |
| 2007 | 13 | 0 |
| 2008 | 22 | 0 |
| 2009 | 18 | 0 |
| 2010 | 7 | 0 |
| 2011 | 8 | 0 |
| 2012 | 7 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 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 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 |
|---|---|---|---|
| * | K092193 | Spinal Usa Interbody CagesSummary page 4…ASTM F1580, and Hydroxyapatite in compliance with ASTM F1185-03. The products are supplied clean and “STERILE”. The cages are included without a coating (already cleared K092193) or with a Cp Ti-HA (Commercially Pure Titanium - Hydroxyapatite) coating (this submission). CHANGE FROM PREDICATE: The purpose… | 2009 |
| * | K161809 | ShurFit CpTi-HA ACIF Interbody Fusion SystemSummary page 5…K092193 Spinal USA Interbody Fusion Device Precision Spine (Spinal USA) K161809 (Primary Predicate) ShurFit CpTi-HA ACIF Interbody Fusion Precision Spine System (Coating Pre… | 2016 |
| * | K150061 | Lucent; Lucent Ti-Bond SystemsSummary page 5…USA) K161809 (Primary Predicate) ShurFit CpTi-HA ACIF Interbody Fusion Precision Spine System (Coating Predicate) K150061 Lucent Ti Bond Systems Spinal Elements K133967 Aurora Spine Inter… | 2015 |
| * | K133967 | Interbody Cage SystemSummary page 5…Fusion Precision Spine System (Coating Predicate) K150061 Lucent Ti Bond Systems Spinal Elements K133967 Aurora Spine Interbody Fusion System Aurora Spine K150321 EVOS HA Lumbar Inter… | 2014 |
| * | K150321 | EVOS Lumbar Interbody SystemSummary page 5…50061 Lucent Ti Bond Systems Spinal Elements K133967 Aurora Spine Interbody Fusion System Aurora Spine K150321 EVOS HA Lumbar Interbody System Cutting Edge Spine… | 2015 |
What descends from it? (4)
3 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 33 years and passes through 13 companies; a new generation was cleared every 1.0 years on median.
- 31 of the 208 ancestors have a recall of any class.
- Of its descendants, K212075 (Precision Spine, Inc., 2021) has gone furthest, with 1 descendant of its own.
- 10 other devices also cite its predicate K092193.
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. 2017, 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 2C Interbody Fusion Devices (LLIF and TLIF) are indicated for intervertebral body fusion of the spine in skeletally mature patients. The device is designed to be used with autograft to facilitate fusion. One device is used per intervertebral space for the LLIF and TLIF. The ShurFit 2C Interbody Fusion Devices (LLIF and TLIF) are intended for use at either one level or two contiguous levels in the lumbar spine, for L2 to S1, for the treatment…
Read the full statement (141 words)
The ShurFit 2C Interbody Fusion Devices (LLIF and TLIF) are indicated for intervertebral body fusion of the spine in
skeletally mature patients. The device is designed to be used with autograft to facilitate fusion. One device is used per
intervertebral space for the LLIF and TLIF.
The ShurFit 2C Interbody Fusion Devices (LLIF and TLIF) are intended for use at either one level or two contiguous
levels in the lumbar spine, for 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/K171657 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171657: ShurFit 2C Lumbar Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171657
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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