510(k) · Cleared
ClearedPoreStar Patient Specific Implant
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 Dec 27, 2017 as substantially equivalent to K083621 (Porex Surgical, Inc., 2009) after a 265-day review. Its family tree reaches back 2 generations to 1992. 1 later device descends from it.
- Decided
- Dec 27, 2017
- Review
- 265 days
- Class
- Class II
- Product code
- JOF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K922489 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK922489 Medpor Surg Implant Material:Prefor Cran/Fac ImplaPorex Technologies Corp. · 1992 · Recalled
- 1 generation backK083621 Medpor Customized Surgical ImplantPorex Surgical, Inc. · 2009
- This deviceK171037 PoreStar Patient Specific ImplantAnatomics Pty, Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK200532 StarPoreAnatomics Pty, Ltd. · 2020
Most influential descendants
Showing 1 of 1 · See all- K200532StarPoreAnatomics Pty, Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922489 | Medpor Surg Implant Material:Prefor Cran/Fac Impla | Porex Technologies Corp. | 1992 | 1 |
| −1 | K083621 | Medpor Customized Surgical Implant | Porex Surgical, Inc. | 2009 | — |
| 0 (this device) | K171037 | PoreStar Patient Specific Implant | Anatomics Pty, Ltd. | 2017 | — |
| +1 | K200532 | StarPore | Anatomics Pty, Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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.
Planning a device in JOF? 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 JOF device
- #1 K200532 StarPorescore 0.0 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K083621 | Medpor Customized Surgical ImplantSummary page 4…Porous Polyethylene Implants Classification Name: 21 CFR 874.3620 Product Code: JOF, GWO Predicate Device: MEDPOR Customized Surgical Implant (K083621) Indications for Use: The PoreStar Patient Specific Implant is intended for the augmentation or restor… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200532 | StarPore | 2020 | 0 |
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 25 years and passes through 3 companies; a new generation was cleared every 16.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K200532 (Anatomics Pty, Ltd., 2020) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K083621.
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. 2017, 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?
The PoreStar Patient Specific Implant is intended for the augmentation or restoration of bony contour in craniofacial defects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171037 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171037: PoreStar Patient Specific Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171037
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