510(k) · Cleared
ClearedBlack Diamond™ POCT Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osseus Fusion Systems · NKG Posterior Cervical Screw System
Cleared on Nov 3, 2022 as substantially equivalent to K172495 (Precision Spine, Inc., 2018) and 2 other predicates after a 108-day review. Its family tree reaches back 18 generations to 1985. 1 of the 283 devices in its family, counting itself, has a Class I recall.
- Decided
- Nov 3, 2022
- Review
- 108 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 18 generations to K853033 (1985). 282 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 283 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 14 generations between
- 3 generations backK150552 ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · Recalled
- 2 generations backK153370 Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated · 2016
- 1 generation backK171444 YUKON OCT Spinal SystemK2m, Inc. · 2017 · Recalled
- This deviceK222107 Black Diamond™ POCT Spinal SystemOsseus Fusion Systems · 2022
Show all 18 generations
- Root · 18 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 17 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 16 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 15 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 14 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 13 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 12 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 11 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 10 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 9 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 8 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 7 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 6 generations backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- 5 generations backK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- 4 generations backK123783 Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013
- 3 generations backK150552 ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · Recalled
- 2 generations backK153370 Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated · 2016
- 1 generation backK171444 YUKON OCT Spinal SystemK2m, Inc. · 2017 · Recalled
- This deviceK222107 Black Diamond™ POCT Spinal SystemOsseus Fusion Systems · 2022
Class I recalls in this family
- K093670 Modification to: Oasys System6 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −17 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −16 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −15 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −14 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −13 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −12 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −11 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −10 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −9 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −8 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −7 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −6 | K101070 | Expedium Spine System | Medos International SARL | 2010 | 1 |
| −5 | K122226 | Revere Stabilization System | Globus Medical, Inc. | 2012 | — |
| −4 | K123783 | Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol Implants | Globus Medical, Inc. | 2013 | — |
| −3 | K150552 | ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS | Globus Medical, Inc. | 2015 | 1 |
| −2 | K153370 | Caspian OCT/MESA Mini/DENALI Mini Spinal System | K2m, Incorporated | 2016 | — |
| −1 | K171444 | YUKON OCT Spinal System | K2m, Inc. | 2017 | 3 |
| 0 (this device) | K222107 | Black Diamond™ POCT Spinal System | Osseus Fusion Systems | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 7 | 0 |
| 1999 | 8 | 0 |
| 2000 | 11 | 0 |
| 2001 | 20 | 0 |
| 2002 | 14 | 0 |
| 2003 | 16 | 0 |
| 2004 | 37 | 0 |
| 2005 | 30 | 0 |
| 2006 | 19 | 0 |
| 2007 | 12 | 0 |
| 2008 | 20 | 0 |
| 2009 | 16 | 0 |
| 2010 | 7 | 1 |
| 2011 | 7 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 12 | 0 |
| 2016 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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.
1 device in this family has a Class I recall. 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 NKG device
- #1 K252327 CMORE® CT System; CMORE® CT System Navigated…score 19.6 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K172495 | Reform® POCT SystemSummary page 4…e Classification: Class II Classification Regulation: 21 CFR 888.3075 Reviewing Panel: Orthopedic Product Code: NKG Predicate Device: K172495 – Precision Spine Reform POCT System Reference Predicate: K131810/K192121 – Osseus Black Diamond™ Pedicle Screw… | 2018 |
| * | K190071 | Perla® Posterior Cervico-Thoracic Fixation SystemSummary page 4…pine Reform POCT System Reference Predicate: K131810/K192121 – Osseus Black Diamond™ Pedicle Screw System Additional Predicates: K190071- Spineart Perla Posterior Cervico-Thoracic Fixation System K171444 –… | 2019 |
| * | K171444 | YUKON OCT Spinal SystemSummary page 4…System Additional Predicates: K190071- Spineart Perla Posterior Cervico-Thoracic Fixation System K171444 – K2M Yukon OCT Spinal System The predicate devices have not been subject to any design related… | 2017 |
| † | K131810 | Osseus Black Diamond Pedicle Screw System | 2013 |
| † | K192121 | Black Diamond Pedicle Screw System | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K093670Modification to: Oasys SystemStryker Spine · 2010 · 6 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 37 years and passes through 10 companies; a new generation was cleared every 1.3 years on median.
- 26 of the 282 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · NKG
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKG
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NKG
153in 2025
MAUDE reports naming product code NKG, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 17 | 71 | 0 | 4 |
| 2016 | 16 | 87 | 0 | 73 |
| 2017 | 15 | 108 | 0 | 99 |
| 2018 | 12 | 61 | 1 | 127 |
| 2019 | 8 | 50 | 1 | 214 |
| 2020 | 14 | 59 | 2 | 236 |
| 2021 | 7 | 56 | 0 | 704 |
| 2022 | 7 | 108 | 0 | 175 |
| 2023 | 10 | 58 | 0 | 131 |
| 2024 | 3 | 100 | 0 | 206 |
| 2025 | 6 | 58 | 0 | 153 |
| 2026 | 4 | 169 | 0 | — |
What is it indicated for?
The Black Diamond™ POCT Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (Cl to C7) and the upper thoracic spine (Tl-T3); traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusion (e.g., pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative…
Read the full statement (168 words)
The Black Diamond™ POCT Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (Cl to C7) and the upper thoracic spine (Tl-T3); traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusion (e.g., pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin, as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Black Diamond™ POCT Spinal System is also intended to restore the integrity of the spinal column even in the absences of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. To achieve additional levels of fixation, the Black Diamond™ POCT Spinal System may be connected to the Osseus Black Diamond™ Pedicle Screw System using transition rods or anatomically-bent rods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222107 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222107: Black Diamond™ POCT Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222107
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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