510(k) · Cleared
ClearedPERLA® Posterior Occipito-Cervico-Thoracic Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineart · NKG Posterior Cervical Screw System
Cleared on May 1, 2020 as substantially equivalent to K110353 (Depuy Spine, Inc., 2011) and 6 other predicates after a 58-day review. Its family tree reaches back 16 generations to 2001. 1 of the 129 devices in its family, counting itself, has a Class I recall.
- Decided
- May 1, 2020
- Review
- 58 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 16 generations to K003155 (2001). 128 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet. 1 of the 129 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 12 generations between
- 3 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
- 2 generations backK121725 Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc. · 2012
- 1 generation backK132504 Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC · 2013
- This deviceK200571 PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart · 2020
Show all 16 generations
- Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 15 generations backK012254 VBROsteotech, Inc. · 2001
- 14 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 13 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 12 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 11 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 7 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
- 6 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 5 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- 4 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 3 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
- 2 generations backK121725 Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc. · 2012
- 1 generation backK132504 Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC · 2013
- This deviceK200571 PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart · 2020
Class I recalls in this family
- K093670 Modification to: Oasys System2 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −15 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −14 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −13 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −12 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −11 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −10 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −7 | K061938 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2006 | — |
| −6 | K062427 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −5 | K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
| −4 | K110522 | Vertex Reconstruction System, Vertex Select Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −3 | K113593 | Nextgen Altius Oct System | Biomet Spine (Aka Ebi, LLC) | 2012 | — |
| −2 | K121725 | Pioneer Posterior Occipito-Cervico-Thoracic (Oct) System | Pioneer Surgical Technology, Inc. | 2012 | — |
| −1 | K132504 | Tiger Occipital-Cervical-Thoracic Spinal Fixation System | Corelink, LLC | 2013 | — |
| 0 (this device) | K200571 | PERLA® Posterior Occipito-Cervico-Thoracic Fixation System | Spineart | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 5 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 9 | 0 |
| 2003 | 7 | 0 |
| 2004 | 25 | 0 |
| 2005 | 11 | 0 |
| 2006 | 5 | 0 |
| 2007 | 5 | 0 |
| 2008 | 7 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 1 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 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? (7)
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 |
|---|---|---|---|
| * | K110353 | Mountaineer Oct Spinal SystemSummary page 4…ORTHOPEDIC Primary predicate: Mountaineer OCT, Summit SI OCT Spinal Fixation System manufactured by Depuy Synthes, Inc (K110353, K151885) Additional predicates: Neon3™ Universal OCT Spinal Stabilization manufactured… | 2011 |
| * | K151885 | SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal SystemSummary page 4…RTHOPEDIC Primary predicate: Mountaineer OCT, Summit SI OCT Spinal Fixation System manufactured by Depuy Synthes, Inc (K110353, K151885) Additional predicates: Neon3™ Universal OCT Spinal Stabilization manufactured by Ulric… | 2015 |
| * | K161032 | neon3™ universal OCT spinal stabilizationSummary page 4…, Inc (K110353, K151885) Additional predicates: Neon3™ Universal OCT Spinal Stabilization manufactured by Ulrich Gmbh & CO. KG (K161032); Vertex Reconstruction System manufactured Legally marketed by Medtronic Sofamor Danek USA, Inc (K143471);… | 2016 |
| * | K143471 | VERTEX Reconstruction SystemSummary page 4…by Ulrich Gmbh & CO. KG (K161032); Vertex Reconstruction System manufactured Legally marketed by Medtronic Sofamor Danek USA, Inc (K143471); Tiger Occipital-Cervical-Thoracic predicate devices Spinal Fixation System manufactured by Corelink LLC (K… | 2015 |
| * | K132504 | Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemSummary page 4…Medtronic Sofamor Danek USA, Inc (K143471); Tiger Occipital-Cervical-Thoracic predicate devices Spinal Fixation System manufactured by Corelink LLC (K132504); Pioneer Posterior Occipito-Cervico-Thoracic (OCT) System manufactured by Pioneer Surgical… | 2013 |
| * | K121725 | Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemSummary page 4…elink LLC (K132504); Pioneer Posterior Occipito-Cervico-Thoracic (OCT) System manufactured by Pioneer Surgical Technology, Inc (K121725); Oasys Spinal System manufactured by Stryker Spine (K111719) The PERLA® posterior occi… | 2012 |
| * | K111719 | Oasys Spinal SystemSummary page 4…cic (OCT) System manufactured by Pioneer Surgical Technology, Inc (K121725); Oasys Spinal System manufactured by Stryker Spine (K111719) The PERLA® posterior occipito-cervico-thoracic fixation system is intended to provide… | 2012 |
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 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 13 of the 128 ancestors have a recall of any class; 1 has a Class I recall.
- 12 other devices also cite its predicate K110353.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 PERLA® posterior occipito-cervico-thoracic fixation 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 crania-cervical junction, the cervical spine (Cl to C7) and the thoracic spine (T to T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving…
Read the full statement (264 words)
The PERLA® posterior occipito-cervico-thoracic fixation 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 crania-cervical junction, the cervical spine (Cl to C7) and the thoracic spine (T to T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical 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 PERLA® posterior occipito-cervico-thoracic fixation system is 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.
The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the cervical spine (CI to C7) and the thoracic spine (T1 to T3).
In order to achieve additional levels of fixation, the PERLA® posterior occipito-cervico-thoracic fixation system may be connected to the ROMEO®2 and PERLA® TL Posterior Osteosynthesis Systems with rod connectors. Transition rods may also be used to connect the PERLA® posterior occipito-cervico-thoracic fixation system to the ROMEO®2 and PERLA®TL Posterior Osteosynthesis Systems. Refer to the ROMEO®2 and PERLA®TL Posterior Osteosynthesis Systems packages inserts for a list of the ROMEO®2 and PERLA®TL Posterior Osteosynthesis Systems indications of use. PERLA® posterior occipito-cervico-thoracic fixation system is indicated for skeletally mature patients.
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/K200571 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200571: PERLA® Posterior Occipito-Cervico-Thoracic Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200571
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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