510(k) · Cleared
ClearedShanghai Sanyou PEEK Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Sanyou Medical Co, Ltd. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Sep 18, 2017 as substantially equivalent to K132897 (Medtronic Sofamor Danek, Inc., 2013) and 4 other predicates after a 286-day review. Its family tree reaches back 16 generations to 1984. 3 later devices descend from it.
- Decided
- Sep 18, 2017
- Review
- 286 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 16 generations to K841189 (1984). 123 ancestors in all, the oldest K792352 (1979). 3 later devices descend from it, 3 citing it directly.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK123027 Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc. · 2013
- 2 generations backK133650 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 1 generation backK151128 CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
- This deviceK163422 Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd. · 2017
- Descendant · cites it directly · 2 of its ownK211689 KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK230872 Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System…Shanghai Sanyou Medical Co, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK254017 SWINGO-3D Lumbar Cage SystemImplanet · 2026
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 backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 6 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 5 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 4 generations backK121760 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 3 generations backK123027 Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc. · 2013
- 2 generations backK133650 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 1 generation backK151128 CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
- This deviceK163422 Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd. · 2017
Most influential descendants
Showing 3 of 3 · See all- K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd. · 2021 · cites it directly2descendants
- K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd. · 2023 · cites it directly1descendant
- K254017SWINGO-3D Lumbar Cage SystemImplanet · 2026 · cites it directly0descendants
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 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −6 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −5 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −4 | K121760 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −3 | K123027 | Capstone (R) Spinal System | Medtronic Sofamor Danek, Inc. | 2013 | — |
| −2 | K133650 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −1 | K151128 | CAPSTONE Spinal System, CLYDESDALE Spinal System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| 0 (this device) | K163422 | Shanghai Sanyou PEEK Cage System | Shanghai Sanyou Medical Co, Ltd. | 2017 | — |
| +1 | K211689 | KEYSTONE PEEK Cage System | Shanghai Sanyou Medical Co, Ltd. | 2021 | — |
| +1 | K230872 | Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™… | Shanghai Sanyou Medical Co, Ltd. | 2023 | — |
| +1 | K254017 | SWINGO-3D Lumbar Cage System | Implanet | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 8 | 0 |
| 2003 | 9 | 0 |
| 2004 | 17 | 0 |
| 2005 | 6 | 0 |
| 2006 | 5 | 0 |
| 2007 | 8 | 0 |
| 2008 | 15 | 0 |
| 2009 | 6 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K132897 | Clydesdale Spinal SystemSummary page 5…n Number: 21 CFR 888.3080 (Intervertebral Body Fusion Device) Panel: 87‐ Orthopedic Product Code: ODP, MAX Primary Predicate Device: K132897 – Medtronic Clydesdale® Spinal System Additional Predicate Devices: K072791 – Depuy Synthes Spine, OPAL Spacer… | 2013 |
| * | K072791 | Oracle Spacer, Opal SpacerSummary page 5…7‐ Orthopedic Product Code: ODP, MAX Primary Predicate Device: K132897 – Medtronic Clydesdale® Spinal System Additional Predicate Devices: K072791 – Depuy Synthes Spine, OPAL Spacer K094025 – Medtronic Sofamor Danek, CRESCENT™ Spinal System… | 2007 |
| * | K094025 | Crescent Spinal SystemSummary page 5…Device: K132897 – Medtronic Clydesdale® Spinal System Additional Predicate Devices: K072791 – Depuy Synthes Spine, OPAL Spacer K094025 – Medtronic Sofamor Danek, CRESCENT™ Spinal System K151128 – Medtronic Sofamor Danek, CAPSTONE® Spinal Sys… | 2010 |
| * | K151128 | CAPSTONE Spinal System, CLYDESDALE Spinal SystemSummary page 5…evices: K072791 – Depuy Synthes Spine, OPAL Spacer K094025 – Medtronic Sofamor Danek, CRESCENT™ Spinal System K151128 – Medtronic Sofamor Danek, CAPSTONE® Spinal System K153373 – Medtronic Sofamor Danek, CORNERSTONE® PSR Cer… | 2015 |
| * | K153373 | CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Summary page 5…K094025 – Medtronic Sofamor Danek, CRESCENT™ Spinal System K151128 – Medtronic Sofamor Danek, CAPSTONE® Spinal System K153373 – Medtronic Sofamor Danek, CORNERSTONE® PSR Cervical Fusion System… | 2016 |
| † | K150765 | LDR Spine ROI-C Cervical Cage System | 2015 |
| † | K121982 | Sovereign Spinal System | 2012 |
What descends from it? (3)
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 11 companies; a new generation was cleared every 1.3 years on median.
- 9 of the 123 ancestors have a recall of any class.
- Of its descendants, K211689 (Shanghai Sanyou Medical Co, Ltd., 2021) has gone furthest, with 2 descendants of its own.
- 12 other devices also cite its predicate K132897.
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. 2017, 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 Halis™ Lumbar Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S 1 whose condition requires use of interbody fusion combined with supplemental fixation. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and…
Read the full statement (446 words)
The Halis™ Lumbar Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S 1 whose condition requires use of interbody fusion combined with supplemental fixation. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have had six months of non-operative treatment prior to surgery. The Halis™ Lumbar Cage System is intended to be used with autogenous bone graft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are intended to be used with supplemental fixation. The devices may be implanted through several surgical approaches: transforaminal, posterior, oblique, and direct lateral. When implanted through the direct lateral approach, the Halis™ Lumbar Cage System is only indicated for use in levels L2-L5.
The Caro™ Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-Tl. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have had six weeks of non-operative treatment prior to surgery. Caro™ Cervical Cage System implants are placed via an anterior approach and is to be used with autogenous bone graft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are intended to be used with supplemental fixation.
The Lydia™ Anterior Lumbar Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a laparoscopic or an open anterior approach. The devices are intended to be used with supplemental fixation. This device is not intended for cervical spine use.
The Dica™ Direction Changeable Lumbar Cage System is indicated for interbody fusion with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have six months of non-operative treatment prior to surgery. The devices are intended to be used with supplemental fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163422 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163422: Shanghai Sanyou PEEK Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163422
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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