510(k) · Cleared
ClearedPERLA® TL System; TEKTONA® HV US Bone Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineart · PML Bone Cement, Posterior Screw Augmentation
Cleared on Jun 23, 2023 as substantially equivalent to K152604 (Medtronic Sofamor Danek USA, Incorporated, 2016) and 4 other predicates after a 94-day review. Its family tree reaches back 23 generations to 2001. 1 of the 671 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 23, 2023
- Review
- 94 days
- Class
- Class II
- Product code
- PML
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 23 generations to K003155 (2001). 670 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 671 devices in this family, counting this one, has a Class I recall.
- Root · 23 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 19 generations between
- 3 generations backK193396 PERLA® TL posterior osteosynthesis systemSpineart · 2020 · Recalled
- 2 generations backK203222 PERLA TL Posterior Osteosynthesis SystemSpineart · 2020
- 1 generation backK213470 PERLA® TL Posterior Osteosynthesis SystemSpineart · 2022
- This deviceK230774 PERLA® TL System; TEKTONA® HV US Bone CementSpineart · 2023
Show all 23 generations
- Root · 23 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 22 generations backK012254 VBROsteotech, Inc. · 2001
- 21 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 20 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 19 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 18 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 17 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 14 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
- 13 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 12 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- 11 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 10 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
- 9 generations backK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
- 8 generations backK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
- 7 generations backK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
- 6 generations backK143248 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014
- 5 generations backK150856 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
- 4 generations backK173130 Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017
- 3 generations backK193396 PERLA® TL posterior osteosynthesis systemSpineart · 2020 · Recalled
- 2 generations backK203222 PERLA TL Posterior Osteosynthesis SystemSpineart · 2020
- 1 generation backK213470 PERLA® TL Posterior Osteosynthesis SystemSpineart · 2022
- This deviceK230774 PERLA® TL System; TEKTONA® HV US Bone CementSpineart · 2023
Class I recalls in this family
- K100952 Modification to Synthes Matrix System6 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −22 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −21 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −20 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −19 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −18 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −17 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −16 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −14 | K061938 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2006 | — |
| −13 | K062427 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −12 | K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
| −11 | K110522 | Vertex Reconstruction System, Vertex Select Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −10 | K113593 | Nextgen Altius Oct System | Biomet Spine (Aka Ebi, LLC) | 2012 | — |
| −9 | K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement System | Biomet Spine (Aka Ebi, LLC) | 2013 | 2 |
| −8 | K131615 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2013 | — |
| −7 | K133746 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2014 | 1 |
| −6 | K143248 | Reform Pedicle Screw System | Precision Spine, Inc. | 2014 | — |
| −5 | K150856 | Reform Pedicle Screw System | Precision Spine, Inc. | 2015 | — |
| −4 | K173130 | Reform® Midline Cortical Screw System | Precision Spine, Inc. | 2017 | — |
| −3 | K193396 | PERLA® TL posterior osteosynthesis system | Spineart | 2020 | 2 |
| −2 | K203222 | PERLA TL Posterior Osteosynthesis System | Spineart | 2020 | — |
| −1 | K213470 | PERLA® TL Posterior Osteosynthesis System | Spineart | 2022 | — |
| 0 (this device) | 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 | 3 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 7 | 0 |
| 1993 | 4 | 0 |
| 1994 | 9 | 0 |
| 1995 | 17 | 0 |
| 1996 | 11 | 0 |
| 1997 | 15 | 0 |
| 1998 | 23 | 0 |
| 1999 | 20 | 0 |
| 2000 | 33 | 0 |
| 2001 | 34 | 0 |
| 2002 | 31 | 0 |
| 2003 | 34 | 0 |
| 2004 | 49 | 0 |
| 2005 | 48 | 0 |
| 2006 | 35 | 0 |
| 2007 | 27 | 0 |
| 2008 | 35 | 0 |
| 2009 | 34 | 0 |
| 2010 | 35 | 1 |
| 2011 | 30 | 0 |
| 2012 | 19 | 0 |
| 2013 | 17 | 0 |
| 2014 | 14 | 0 |
| 2015 | 15 | 0 |
| 2016 | 10 | 0 |
| 2017 | 11 | 0 |
| 2018 | 6 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 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 PML device
- #1 K200596 G21 Cement, VADER® Pedicle Systemscore 24.9 · 20 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 |
|---|---|---|---|
| * | K152604 | KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetSummary page 5…NKB KWP Primary Predicate: KYPHON HV-R® Fenestrated Screw Cement, CD Horizon® Fenestrated Screw Set (K152604) Additional Predicates: PERLA®TL Posterior Osteosynthesis System (K213470), TEK… | 2016 |
| * | K213470 | PERLA® TL Posterior Osteosynthesis SystemSummary page 5…ew Cement, CD Horizon® Fenestrated Screw Set (K152604) Additional Predicates: PERLA®TL Posterior Osteosynthesis System (K213470), TEKTONA HV US Bone Cement (K122175), NEO Pedicle Screw System™ (K212489), G21… | 2022 |
| * | K122175 | Mendec Spine HV, Mendec Spine HV SystemSummary page 5…rew Set (K152604) Additional Predicates: PERLA®TL Posterior Osteosynthesis System (K213470), TEKTONA HV US Bone Cement (K122175), NEO Pedicle Screw System™ (K212489), G21 Cement & VADER Pedicle Screw System… | 2013 |
| * | K212489 | BonOs Inject Bone Cement; NEO Pedicle Screw SystemSummary page 5…PERLA®TL Posterior Osteosynthesis System (K213470), TEKTONA HV US Bone Cement (K122175), NEO Pedicle Screw System™ (K212489), G21 Cement & VADER Pedicle Screw System (K200596)… | 2021 |
| * | K200596 | G21 Cement, VADER® Pedicle SystemSummary page 5…ement (K122175), NEO Pedicle Screw System™ (K212489), G21 Cement & VADER Pedicle Screw System (K200596) K230774… | 2020 |
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 · 6 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 86 of the 670 ancestors have a recall of any class; 1 has a Class I recall.
- 12 other devices also cite its predicate K152604.
How does its category compare?
All PML devicesPML Bone Cement, Posterior Screw Augmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · PML
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PML
116in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PML
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PML
55in 2025
MAUDE reports naming product code PML, 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 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 34 |
| 2019 | 2 | — | 0 | 35 |
| 2020 | 3 | 182 | 0 | 27 |
| 2021 | 1 | — | 0 | 32 |
| 2022 | 2 | — | 0 | 12 |
| 2023 | 3 | 116 | 2 | 18 |
| 2024 | 1 | — | 0 | 60 |
| 2025 | 0 | — | 0 | 55 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The PERLA® TL 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…
Read the full statement (333 words)
The PERLA® TL 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 system is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PERLA® TL system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
When used in conjunction with TEKTONA® HV US bone cement system, the PERLA® TL system is intended to restore the integrity of the spinal column even in the absence of fusion for a limited period of time, in patients whom life expectancy is of insufficient duration to permit achievement of fusion in advanced stage of thoracic and lumbar spine tumors. The PERLA® TL 35mm to 60mm lengths Screws augmented used with TEKTONA® HV US bone cement system are intended to be used at spinal levels where the structural integrity is not severely compromised.
TEKTONA® HV US Bone Cement is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
When used in conjunction with PERLA® TL system, TEKTONA® HV US Bone Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. PERLA® TL Screws augmented with TEKTONA® HV US Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
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/K230774 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230774: PERLA® TL System; TEKTONA® HV US Bone Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230774
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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