510(k) · Cleared
ClearedShurFit CpTi-HA ACIF Interbody Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Spine, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Dec 6, 2016 as substantially equivalent to K083118 (Spinal USA, 2009) and 4 other predicates after a 158-day review. Its family tree reaches back 16 generations to 1984. 5 later devices descend from it.
- Decided
- Dec 6, 2016
- Review
- 158 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 16 generations to K841189 (1984). 179 ancestors in all, the oldest K792352 (1979). 5 later devices descend from it, 1 citing it directly.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK102547 Coroent Interlock SystemNuvasive, Inc. · 2011
- 2 generations backK131429 Reliance Cervical Ibf SystemReliance Medical Systems, LLC · 2013
- 1 generation backK142269 Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2015
- This deviceK161809 ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. · 2016
- Descendant · cites it directly · 4 of its ownK171657 ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK212075 ShurFit Lumbar Interbody SystemPrecision Spine, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK221182 Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK221172 FOCUS Interbody SystemOc Medical Devices · 2022
- Descendant · 2 generations on · 0 of its ownK212070 KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc. · 2021
Show all 16 generations
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 14 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 13 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 10 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 9 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 6 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 5 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 4 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 3 generations backK102547 Coroent Interlock SystemNuvasive, Inc. · 2011
- 2 generations backK131429 Reliance Cervical Ibf SystemReliance Medical Systems, LLC · 2013
- 1 generation backK142269 Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2015
- This deviceK161809 ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. · 2016
Most influential descendants
Showing 5 of 5 · See all- K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc. · 2017 · cites it directly4descendants
- K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc. · 2021 · 2 generations on1descendant
- K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd. · 2022 · 2 generations on0descendants
- K221172FOCUS Interbody SystemOc Medical Devices · 2022 · 3 generations on0descendants
- K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −15 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −14 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −13 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −10 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −9 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −6 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −5 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −4 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −3 | K102547 | Coroent Interlock System | Nuvasive, Inc. | 2011 | — |
| −2 | K131429 | Reliance Cervical Ibf System | Reliance Medical Systems, LLC | 2013 | — |
| −1 | K142269 | Reliance Cervical IBF System | Reliance Medical Systems, LLC | 2015 | — |
| 0 (this device) | K161809 | ShurFit CpTi-HA ACIF Interbody Fusion System | Precision Spine, Inc. | 2016 | — |
| +1 | K171657 | ShurFit 2C Lumbar Interbody Fusion System | Precision Spine, Inc. | 2017 | — |
| +2 | K212075 | ShurFit Lumbar Interbody System | Precision Spine, Inc. | 2021 | — |
| +2 | K221182 | Southern Transforaminal Lumbar Interbody Fusion (TLIF) | Southern Medical (Pty), Ltd. | 2022 | — |
| +3 | K221172 | FOCUS Interbody System | Oc Medical Devices | 2022 | — |
| +2 | 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 | 14 | 0 |
| 2004 | 24 | 0 |
| 2005 | 15 | 0 |
| 2006 | 9 | 0 |
| 2007 | 11 | 0 |
| 2008 | 19 | 0 |
| 2009 | 14 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 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 ODP? 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 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 |
|---|---|---|---|
| * | K083118 | Spinal Usa Anterior Cervical Interbody Fusion DeviceSummary page 4…manufactured from medical grade polyetheretherketone as described by ASTM F2026, specifically PEEK Optima LT1. The cages are included without a coating (already cleared K083118) or with a CpTi-HA (Commercially Pure Titanium - Hydroxyapatite) coating (this submission). CHANGE FROM PREDICATE: The purpose o… | 2009 |
| * | K142269 | Reliance Cervical IBF SystemSummary page 5…Interbody Fusion Device Precision Spine Primary ACIF System (Spinal USA) K142269 Reliance HA Infused Reliance Additional… | 2015 |
| * | K142026 | Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion DeviceSummary page 5…Additional Cervical IBF Medical Systems K142026 Arena-C HA infused Spine Frontier Additional… | 2014 |
| * | K112036 | Calix PC Spinal Implant SystemSummary page 5…Systems K142026 Arena-C HA infused Spine Frontier Additional Cervical cage K112036 Calix PC Titanium coated X Spine Additional… | 2011 |
| * | K123909 | Aesculap Cespace XPSummary page 5…Cervical cage K112036 Calix PC Titanium coated X Spine Additional Cervical cage K123909 CeSpace Titanium coated Aesculap Additional… | 2013 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171657 | ShurFit 2C Lumbar Interbody Fusion System | 2017 | 4 |
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 1.5 years on median.
- 27 of the 179 ancestors have a recall of any class.
- Of its descendants, K171657 (Precision Spine, Inc., 2017) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K083118.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
The ShurFit CpTi-HA Coated Anterior Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. ShurFit Anterior Cervical Interbody Fusion System implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device. The device should be used with supplemental fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161809 · printed Nov 4, 2026
Cite this page
510(k) Report. “K161809: ShurFit CpTi-HA ACIF Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K161809
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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