510(k) · Cleared
ClearedCove Strip, OsteoCove Strip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SeaSpine Orthopedics Corporation · MQV Filler, Bone Void, Calcium Compound
Cleared on Sep 27, 2023 as substantially equivalent to K230486 (SeaSpine Orthopedics Corporation, 2023) after a 26-day review. Its family tree reaches back 10 generations to 1996.
- Decided
- Sep 27, 2023
- Review
- 26 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K960978 (1996). 35 ancestors in all, the oldest K871773 (1987). No later device cites it as a predicate yet.
- Root · 10 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 6 generations between
- 3 generations backK082166 Mastergraft StripMedtronic Sofamor Danek · 2009
- 2 generations backK140375 Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014
- 1 generation backK230486 Cove StripSeaSpine Orthopedics Corporation · 2023
- This deviceK232668 Cove Strip, OsteoCove StripSeaSpine Orthopedics Corporation · 2023
Show all 10 generations
- Root · 10 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 9 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 8 generations backK000515 Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051…Interpore Cross Intl. · 2000
- 7 generations backK012751 Healos Bone Graft MaterialOrquest, Inc. · 2001
- 6 generations backK043308 Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005
- 5 generations backK051386 Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005
- 4 generations backK071813 Mastergraft PuttyMedtronic Sofamor Danek · 2007
- 3 generations backK082166 Mastergraft StripMedtronic Sofamor Danek · 2009
- 2 generations backK140375 Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014
- 1 generation backK230486 Cove StripSeaSpine Orthopedics Corporation · 2023
- This deviceK232668 Cove Strip, OsteoCove StripSeaSpine Orthopedics Corporation · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −9 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −8 | K000515 | Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101… | Interpore Cross Intl. | 2000 | — |
| −7 | K012751 | Healos Bone Graft Material | Orquest, Inc. | 2001 | — |
| −6 | K043308 | Modification to: Healos Bone Graft Material | Depuy Spine, Inc. | 2005 | — |
| −5 | K051386 | Mastergraft Putty Bone Void Filler | Medtronic Vascular | 2005 | — |
| −4 | K071813 | Mastergraft Putty | Medtronic Sofamor Danek | 2007 | — |
| −3 | K082166 | Mastergraft Strip | Medtronic Sofamor Danek | 2009 | — |
| −2 | K140375 | Mastergraft Putty, Mastergraft Strip | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −1 | K230486 | Cove Strip | SeaSpine Orthopedics Corporation | 2023 | — |
| 0 (this device) | K232668 | Cove Strip, OsteoCove Strip | SeaSpine Orthopedics Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 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 MQV? 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 MQV device
- #1 K232315 Catalyst Bone Void Fillerscore 25.2 · 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? (1)
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 |
|---|---|---|---|
| * | K230486 | Cove StripSummary page 6…MQV Legally Marketed Predicate Device 510(k) Number Product Code Trade Name Manufacturer Primary Predicate Device K230486 MQV Cove Strip, OsteoCove Strip IsoTis OrthoBiologics, Inc. Device Description Cove Strip: Cove Strip… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 9 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 35 ancestors have a recall of any class.
How does its category compare?
All MQV devicesMQV Filler, Bone Void, Calcium Compound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MQV
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQV
57in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQV
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQV
57in 2025
MAUDE reports naming product code MQV, 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 | 35 | 144 | 5 | 67 |
| 2008 | 32 | 102 | 3 | 71 |
| 2009 | 23 | 180 | 1 | 81 |
| 2010 | 17 | 147 | 0 | 68 |
| 2011 | 16 | 92 | 6 | 114 |
| 2012 | 9 | 107 | 3 | 149 |
| 2013 | 12 | 197 | 2 | 223 |
| 2014 | 20 | 153 | 0 | 111 |
| 2015 | 18 | 184 | 0 | 125 |
| 2016 | 8 | 214 | 1 | 106 |
| 2017 | 17 | 124 | 1 | 107 |
| 2018 | 23 | 124 | 2 | 86 |
| 2019 | 13 | 90 | 0 | 65 |
| 2020 | 15 | 132 | 1 | 126 |
| 2021 | 8 | 88 | 0 | 101 |
| 2022 | 9 | 118 | 0 | 47 |
| 2023 | 21 | 74 | 3 | 120 |
| 2024 | 28 | 55 | 2 | 68 |
| 2025 | 14 | 57 | 1 | 57 |
| 2026 | 5 | 96 | 4 | — |
What is it indicated for?
Cove Strip is an implant intended to fill bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Cove Strip resorbs and is replaced with bone during the healing process. Cove Strip must be used with autograft as a bone graft extender in the posterolateral spine and pelvis.…
Read the full statement (154 words)
Cove Strip is an implant intended to fill bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Cove Strip resorbs and is replaced with bone during the healing process. Cove Strip must be used with autograft as a bone graft extender in the posterolateral spine and pelvis.
OsteoCove Strip is an implant intended to fill bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. OsteoCove Strip resorbs and is replaced with bone during the healing process. OsteoCove Strip must be used with autograft as a bone graft extender in the posterolateral spine and pelvis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K232668 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232668: Cove Strip, OsteoCove Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232668
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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