510(k) · Cleared
ClearedStarPore
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anatomics Pty, Ltd. · JOF Polymer, Ent Synthetic, Porous Polyethylene
Cleared on Jun 2, 2020 as substantially equivalent to K171037 (Anatomics Pty, Ltd., 2017) after a 92-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Jun 2, 2020
- Review
- 92 days
- Class
- Class II
- Product code
- JOF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K922489 (1992). No later device cites it as a predicate yet.
- Root · 3 generations backK922489 Medpor Surg Implant Material:Prefor Cran/Fac ImplaPorex Technologies Corp. · 1992 · Recalled
- 2 generations backK083621 Medpor Customized Surgical ImplantPorex Surgical, Inc. · 2009
- 1 generation backK171037 PoreStar Patient Specific ImplantAnatomics Pty, Ltd. · 2017
- This deviceK200532 StarPoreAnatomics Pty, Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922489 | Medpor Surg Implant Material:Prefor Cran/Fac Impla | Porex Technologies Corp. | 1992 | 1 |
| −2 | K083621 | Medpor Customized Surgical Implant | Porex Surgical, Inc. | 2009 | — |
| −1 | K171037 | PoreStar Patient Specific Implant | Anatomics Pty, Ltd. | 2017 | — |
| 0 (this device) | K200532 | StarPore | Anatomics Pty, Ltd. | 2020 | — |
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.
Planning a device in JOF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K171037 | PoreStar Patient Specific ImplantSummary page 4…mer Material) Panel: Ear, Nose, and Throat Product Code: JOF Predicate Device: • Anatomics Pty Ltd. PoreStar Patient Specific Implant – K171037 Reference Devices: • Porex MEDPOR Surg Implant Material: Prefor Cran/Fac Impla - K922489 • Porex MEDPOR Plus Surgic… | 2017 |
| † | K922489 | Medpor Surg Implant Material:Prefor Cran/Fac Impla | 1992 |
| † | K012350 | Medpor Plus Surgical Implant Biomaterial | 2002 |
| † | K002586 | Medpor Pterional Surgical Implant | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 8.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All JOF devicesJOF Polymer, Ent Synthetic, Porous Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · JOF
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · JOF
Too few JOF 510(k)s in any year since 2007 to give a median.
Recalls per year · JOF
No recall names JOF since 2007.
Adverse event reports per year · JOF
20in 2023
MAUDE reports naming product code JOF, 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 | 3 |
| 2009 | 1 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 15 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 20 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
StarPore™ implants are intended for the restoration or augmentation of bony contour in craniofacial defects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200532 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200532: StarPore.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200532
Report an extraction error
Are you the manufacturer?
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