510(k) · Cleared
ClearedZ-LINKPC System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zavation Medical Products, LLC · NKG Posterior Cervical Screw System
Cleared on Aug 11, 2021 as substantially equivalent to K180198 (Nu Vasive, Incorporated, 2018) and 1 other predicate after a 44-day review. Its family tree reaches back 19 generations to 2004. 1 of the 332 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 11, 2021
- Review
- 44 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 19 generations to K040583 (2004). 331 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet. 1 of the 332 devices in this family, counting this one, has a Class I recall.
- Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations between
- 3 generations backK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
- 2 generations backK161014 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
- 1 generation backK180198 NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated · 2018
- This deviceK211993 Z-LINKPC SystemZavation Medical Products, LLC · 2021
Show all 19 generations
- Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 18 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 17 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 16 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 15 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 14 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 13 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 12 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 11 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 10 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 9 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 8 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 7 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 6 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 5 generations backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 4 generations backK141604 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 3 generations backK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
- 2 generations backK161014 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
- 1 generation backK180198 NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated · 2018
- This deviceK211993 Z-LINKPC SystemZavation Medical Products, LLC · 2021
Class I recalls in this family
- K100952 Modification to Synthes Matrix System5 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −18 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −17 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −16 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −15 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −14 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −13 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −12 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −11 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −10 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −9 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −8 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −7 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −6 | K131321 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −5 | K132111 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −4 | K141604 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −3 | K143684 | NuVasive Reline System | Nu Vasive, Incorporated | 2015 | — |
| −2 | K161014 | NuVasive® Reline® System | Nu Vasive, Incorporated | 2016 | — |
| −1 | K180198 | NuVasive® VuePoint® II OCT System | Nu Vasive, Incorporated | 2018 | — |
| 0 (this device) | K211993 | Z-LINKPC System | Zavation Medical Products, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 13 | 0 |
| 1996 | 8 | 0 |
| 1997 | 11 | 0 |
| 1998 | 15 | 0 |
| 1999 | 14 | 0 |
| 2000 | 23 | 0 |
| 2001 | 25 | 0 |
| 2002 | 17 | 0 |
| 2003 | 21 | 0 |
| 2004 | 32 | 0 |
| 2005 | 24 | 0 |
| 2006 | 15 | 0 |
| 2007 | 13 | 0 |
| 2008 | 16 | 0 |
| 2009 | 8 | 0 |
| 2010 | 9 | 1 |
| 2011 | 7 | 0 |
| 2012 | 1 | 0 |
| 2013 | 5 | 0 |
| 2014 | 6 | 0 |
| 2015 | 7 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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? (2)
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 |
|---|---|---|---|
| * | K180198 | NuVasive® VuePoint® II OCT SystemSummary page 5…anufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136, and cobalt chromium alloy (Co-28Cr-6Mo) as described by ASTM F1537. Primary Predicate Device: K180198 Nuvasive Viewpoint Additional Predicate Device: K180025 Orthofix Centurion Technological Characteristics: The Z-LINKPC system p… | 2018 |
| * | K180025 | Centurion POCT SystemSummary page 5…bed by ASTM F136, and cobalt chromium alloy (Co-28Cr-6Mo) as described by ASTM F1537. Primary Predicate Device: K180198 Nuvasive Viewpoint Additional Predicate Device: K180025 Orthofix Centurion Technological Characteristics: The Z-LINKPC system possesses the same technological characteristics as the pr… | 2018 |
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.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 5 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 6 companies; a new generation was cleared every 6 months on median.
- 38 of the 331 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K180198.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Z-LINKPC System implants are 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 (C1-C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including…
Read the full statement (185 words)
The Z-LINKPC System implants are 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 (C1-C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (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. These implants are also intended to restore the integrity of the spinal column even in the absence 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 Z-LINKPC System may be connected to the Zavation Spinal System using rod connectors and tapered rods.
When used with the occipital plate, the Z-LINKPC System is also intended to provide immobilization and stabilization for the occipito-cervico-thoracic juction (occiput-T3) in treatment of the instabilities mentioned above, including occipitocervical dislocation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211993 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211993: Z-LINKPC System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211993
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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