510(k) · Cleared
ClearedKEYSTONE 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. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Sep 21, 2021 as substantially equivalent to K083026 (Medtronic Sofamor Danek, 2008) and 3 other predicates after a 111-day review. Its family tree reaches back 17 generations to 1984. 2 later devices descend from it.
- Decided
- Sep 21, 2021
- Review
- 111 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 17 generations to K841189 (1984). 124 ancestors in all, the oldest K792352 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK133650 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 2 generations backK151128 CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 1 generation backK163422 Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd. · 2017
- This deviceK211689 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 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 backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 7 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 6 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 5 generations backK121760 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 4 generations backK123027 Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc. · 2013
- 3 generations backK133650 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 2 generations backK151128 CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 1 generation backK163422 Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd. · 2017
- This deviceK211689 KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd. · 2021
Most influential descendants
Showing 2 of 2 · See allView 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 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −7 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −6 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −5 | K121760 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −4 | K123027 | Capstone (R) Spinal System | Medtronic Sofamor Danek, Inc. | 2013 | — |
| −3 | K133650 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −2 | K151128 | CAPSTONE Spinal System, CLYDESDALE Spinal System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −1 | K163422 | Shanghai Sanyou PEEK Cage System | Shanghai Sanyou Medical Co, Ltd. | 2017 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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 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? (4)
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 |
|---|---|---|---|
| * | K083026 | Clydesdale Spinal SystemSummary page 5…ence: The subject KEYSTONE PEEK Cage System is substantially equivalent to the following predicate devices: Primary Predicate: Medtronic, CLYDESDALE® Spinal System: K083026, K132897, K151128 Secondary Predicates: Shanghai Sanyou PEEK Cage System Halis Cage: K163422 There are insignificant… | 2008 |
| * | K132897 | Clydesdale Spinal SystemSummary page 5…subject KEYSTONE PEEK Cage System is substantially equivalent to the following predicate devices: Primary Predicate: Medtronic, CLYDESDALE® Spinal System: K083026, K132897, K151128 Secondary Predicates: Shanghai Sanyou PEEK Cage System Halis Cage: K163422 There are insignificant differen… | 2013 |
| * | K151128 | CAPSTONE Spinal System, CLYDESDALE Spinal SystemSummary page 5…KEYSTONE PEEK Cage System is substantially equivalent to the following predicate devices: Primary Predicate: Medtronic, CLYDESDALE® Spinal System: K083026, K132897, K151128 Secondary Predicates: Shanghai Sanyou PEEK Cage System Halis Cage: K163422 There are insignificant differences betwe… | 2015 |
| * | K163422 | Shanghai Sanyou PEEK Cage SystemSummary page 5…devices: Primary Predicate: Medtronic, CLYDESDALE® Spinal System: K083026, K132897, K151128 Secondary Predicates: Shanghai Sanyou PEEK Cage System Halis Cage: K163422 There are insignificant differences between the subject KEYSTONE PEEK Cage System and the predicates. The Indicati… | 2017 |
What descends from it? (2)
2 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 37 years and passes through 11 companies; a new generation was cleared every 1.3 years on median.
- 9 of the 124 ancestors have a recall of any class.
- Of its descendants, K230872 (Shanghai Sanyou Medical Co, Ltd., 2023) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K083026.
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 KEYSTONE PEEK Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2 toS1 whose condition requires use of interbody fusion combined with supplemental fixation. 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…
Read the full statement (185 words)
The KEYSTONE PEEK Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2 toS1 whose condition requires use of interbody fusion combined with supplemental fixation. 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. Additionally, the KEYSTONE PEEK Cage System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. Patients should have had six months of non-operative treatment prior to surgery. The KEYSTONE PEEK Cage System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion. When used for these indications, the KEYSTONE PEEK Cage System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. These implants may be implanted via a minimally invasive lateral approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211689 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211689: KEYSTONE PEEK Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211689
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