510(k) · Cleared
Recalled · Class II · 2025PERLA® TL posterior osteosynthesis system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineart · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jan 15, 2021 as substantially equivalent to K081165 (Spineart, 2008) and 4 other predicates after a 46-day review. Its family tree reaches back 21 generations to 2001. 1 of the 520 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 15, 2021
- Review
- 46 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 21 generations to K003155 (2001). 516 ancestors in all, the oldest K781443 (1978). 3 later devices descend from it, 1 citing it directly. 1 of the 520 devices in this family, counting this one, has a Class I recall.
- Root · 21 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 17 generations between
- 3 generations backK150856 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
- 2 generations backK173130 Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017
- 1 generation backK193396 PERLA® TL posterior osteosynthesis systemSpineart · 2020 · Recalled
- This deviceK203506 PERLA® TL posterior osteosynthesis systemSpineart · 2021
- Descendant · cites it directly · 2 of its ownK213470 PERLA® TL Posterior Osteosynthesis SystemSpineart · 2022
- Descendant · 2 generations on · 0 of its ownK253966 PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA · 2026
- Descendant · 2 generations on · 0 of its ownK230774 PERLA® TL System; TEKTONA® HV US Bone CementSpineart · 2023
Show all 21 generations
- Root · 21 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 20 generations backK012254 VBROsteotech, Inc. · 2001
- 19 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 18 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 17 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 16 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 12 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
- 11 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 10 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- 9 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 8 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
- 7 generations backK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
- 6 generations backK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
- 5 generations backK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
- 4 generations backK143248 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014
- 3 generations backK150856 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
- 2 generations backK173130 Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017
- 1 generation backK193396 PERLA® TL posterior osteosynthesis systemSpineart · 2020 · Recalled
- This deviceK203506 PERLA® TL posterior osteosynthesis systemSpineart · 2021
Class I recalls in this family
- K100952 Modification to Synthes Matrix System5 generations back · 2010
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −20 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −19 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −18 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −17 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −16 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −13 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −12 | K061938 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2006 | — |
| −11 | K062427 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −10 | K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
| −9 | K110522 | Vertex Reconstruction System, Vertex Select Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −8 | K113593 | Nextgen Altius Oct System | Biomet Spine (Aka Ebi, LLC) | 2012 | — |
| −7 | K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement System | Biomet Spine (Aka Ebi, LLC) | 2013 | 2 |
| −6 | K131615 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2013 | — |
| −5 | K133746 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2014 | 1 |
| −4 | K143248 | Reform Pedicle Screw System | Precision Spine, Inc. | 2014 | — |
| −3 | K150856 | Reform Pedicle Screw System | Precision Spine, Inc. | 2015 | — |
| −2 | K173130 | Reform® Midline Cortical Screw System | Precision Spine, Inc. | 2017 | — |
| −1 | K193396 | PERLA® TL posterior osteosynthesis system | Spineart | 2020 | 2 |
| 0 (this device) | K203506 | PERLA® TL posterior osteosynthesis system | Spineart | 2021 | — |
| +1 | K213470 | PERLA® TL Posterior Osteosynthesis System | Spineart | 2022 | — |
| +2 | K253966 | PERLA® TL Posterior Thoraco-lumbar Fixation System | Spineart SA | 2026 | — |
| +2 | K230774 | PERLA® TL System; TEKTONA® HV US Bone Cement | Spineart | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 4 | 0 |
| 1994 | 5 | 0 |
| 1995 | 10 | 0 |
| 1996 | 10 | 0 |
| 1997 | 10 | 0 |
| 1998 | 19 | 0 |
| 1999 | 13 | 0 |
| 2000 | 27 | 0 |
| 2001 | 30 | 0 |
| 2002 | 28 | 0 |
| 2003 | 29 | 0 |
| 2004 | 43 | 0 |
| 2005 | 40 | 0 |
| 2006 | 30 | 0 |
| 2007 | 20 | 0 |
| 2008 | 31 | 0 |
| 2009 | 28 | 0 |
| 2010 | 30 | 1 |
| 2011 | 24 | 0 |
| 2012 | 15 | 0 |
| 2013 | 8 | 0 |
| 2014 | 9 | 0 |
| 2015 | 8 | 0 |
| 2016 | 4 | 0 |
| 2017 | 6 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 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.
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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K081165 | Ellipse Lumbar Posterior Osteosynthesis SystemSummary page 4….3070 , 888.3050 Device panel ORTHOPEDIC Primary predicate: ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM by Spineart (K081165) Legally marketed Additional predicates: PERLA® TL Posterior Osteosynthesis System by Spineart predicate dev… | 2008 |
| * | K193396 | PERLA® TL posterior osteosynthesis systemSummary page 4…510(k) SUMMARY 510k TRADITIONAL Basis for submission Product Line Extension of the Perla® TL system previously cleared (K193396) SPINEART 3 Chemin du Pré Fleuri Submitted by 1228 PLAN LES OUATES… | 2020 |
| * | K093936 | Romeo Posterior Osteosynthesis SystemSummary page 4…nal predicates: PERLA® TL Posterior Osteosynthesis System by Spineart predicate devices (K193396) ROMEO Posterior Osteosynthesis System by Spineart (K093936) and CD HORIZON by Medtronic (K152457, K170347) The PERLA® TL posterior osteosynthesis… | 2010 |
| * | K152457 | CD HORIZON Spinal SystemSummary page 4…y Spineart predicate devices (K193396) ROMEO Posterior Osteosynthesis System by Spineart (K093936) and CD HORIZON by Medtronic (K152457, K170347) The PERLA® TL posterior osteosynthesis system is intended to provide immobili… | 2015 |
| * | K170347 | CD HORIZON™ Fenestrated Screw SetSummary page 4…t predicate devices (K193396) ROMEO Posterior Osteosynthesis System by Spineart (K093936) and CD HORIZON by Medtronic (K152457, K170347) The PERLA® TL posterior osteosynthesis system is intended to provide immobilization an… | 2017 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213470 | PERLA® TL Posterior Osteosynthesis System | 2022 | 2 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 30, 2025 | Class II | Z-2279-2025 | Labeling Change Control | Cannulated fenestrated polyaxial screws may be incorrectly labeled |
| Jun 30, 2025 | Class II | Z-2280-2025 | Labeling Change Control | Cannulated fenestrated polyaxial screws may be incorrectly labeled |
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 20 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 62 of the 516 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K213470 (Spineart, 2022) has gone furthest, with 2 descendants of its own.
- 11 other devices also cite its predicate K081165.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle 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 · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The PERLA® TL posterior osteosynthesis system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used…
Read the full statement (113 words)
The PERLA® TL posterior osteosynthesis system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the PERLA® TL posterior osteosynthesis system is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis.
The PERLA® TL posterior osteosynthesis system is intended to be used with autograft and/or allograft.
Pediatric pedicle screw fixation is limited to a posterior approach.
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/K203506 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203506: PERLA® TL posterior osteosynthesis system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203506
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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