510(k) · Cleared
ClearedMedpor Fixation System-Cranial, Models 80080, 80079
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Porex Surgical, Inc. · HBW Fastener, Plate, Cranioplasty
Cleared on Dec 3, 2010 as substantially equivalent to K073006 (Takiron Co., Ltd., 2008) and 4 other predicates after a 155-day review. Its family tree reaches back 8 generations to 1990.
- Decided
- Dec 3, 2010
- Review
- 155 days
- Class
- Class II
- Product code
- HBW
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K904436 (1990). 85 ancestors in all, the oldest K761228 (1976). No later device cites it as a predicate yet.
- Root · 8 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 7 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 6 generations backK972783 Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc. · 1998
- 5 generations backK982139 Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998
- 4 generations backK982721 Biosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation SystemBionx Implants, Inc. · 1999
- 3 generations backK011569 Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc. · 2002
- 2 generations backK061881 Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2007
- 1 generation backK073006 Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008
- This deviceK101835 Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −7 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −6 | K972783 | Biofix Biodegradable Threaded Suture Anchor | Bionx Implants, Inc. | 1998 | — |
| −5 | K982139 | Biosorbfx 1.5/2.0 Bioabsorbable Fixation System | Bionx Implants, Inc. | 1998 | — |
| −4 | K982721 | Biosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation System | Bionx Implants, Inc. | 1999 | — |
| −3 | K011569 | Biosorbfx O/M 2.0/2/4 System | Bionx Implants, Inc. | 2002 | — |
| −2 | K061881 | Osteotrans -MX Bioabsorbable Bone Fixation System | Takiron Co., Ltd. | 2007 | — |
| −1 | K073006 | Osteotrans -MX Bioabsorbable Bone Fixation System | Takiron Co., Ltd. | 2008 | — |
| 0 (this device) | K101835 | Medpor Fixation System-Cranial, Models 80080, 80079 | Porex Surgical, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1986 | 3 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 4 | 0 |
| 1994 | 5 | 0 |
| 1995 | 6 | 0 |
| 1996 | 10 | 0 |
| 1997 | 8 | 0 |
| 1998 | 11 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 6 | 0 |
| 2003 | 2 | 0 |
| 2006 | 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 HBW? 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 HBW device
- #1 K251472 Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation…score 10.0 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K073006 | Osteotrans -MX Bioabsorbable Bone Fixation SystemSummary page 1…CFR 882.5360 - Cranioplasty plate fastener Product Code: HBW Substantially equivalent to: 1) Takiron Co., Ltd OSTEOTRANSTM-MX Bioabsorbable Bone Fixation System K073006 2) Synthes (USA) Synthes Low Profile Neuro System K022012 3) Synthes (USA) Synthes (USA) Craniofacial Plates K02 16… | 2008 |
| * | K022012 | Synthes Low Profile Neuro SystemSummary page 1…bstantially equivalent to: 1) Takiron Co., Ltd OSTEOTRANSTM-MX Bioabsorbable Bone Fixation System K073006 2) Synthes (USA) Synthes Low Profile Neuro System K022012 3) Synthes (USA) Synthes (USA) Craniofacial Plates K02 1642 4) Synthes (USA) SME Titanium (TI) Alloy Bone Screws K9… | 2002 |
| * | K021642 | Synthes Craniofacial PlatesSummary page 1…Bioabsorbable Bone Fixation System K073006 2) Synthes (USA) Synthes Low Profile Neuro System K022012 3) Synthes (USA) Synthes (USA) Craniofacial Plates K02 1642 4) Synthes (USA) SME Titanium (TI) Alloy Bone Screws K963546 5) Stryker Leibinger Stryker Leibinger Universal Neuro Sy… | 2002 |
| * | K963546 | SMF Titanium (TI) Alloy Bone ScrewsSummary page 1…ynthes Low Profile Neuro System K022012 3) Synthes (USA) Synthes (USA) Craniofacial Plates K02 1642 4) Synthes (USA) SME Titanium (TI) Alloy Bone Screws K963546 5) Stryker Leibinger Stryker Leibinger Universal Neuro System K03 1659 5-1 ==… | 1997 |
| * | K031659 | Universal Neuro SystemSummary page 1…Craniofacial Plates K02 1642 4) Synthes (USA) SME Titanium (TI) Alloy Bone Screws K963546 5) Stryker Leibinger Stryker Leibinger Universal Neuro System K03 1659 5-1 Device Description: The MEDPOR Fixation System - Cranial is a pl… | 2003 |
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 20 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 8 of the 85 ancestors have a recall of any class.
- 1 other device also cites its predicate K073006.
How does its category compare?
All HBW devicesHBW Fastener, Plate, Cranioplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · HBW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HBW
Too few HBW 510(k)s in any year since 2007 to give a median.
Recalls per year · HBW
No recall names HBW since 2007.
Adverse event reports per year · HBW
3in 2025
MAUDE reports naming product code HBW, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 14 |
| 2018 | 0 | — | 0 | 22 |
| 2019 | 0 | — | 0 | 20 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MEDPOR Fixation System - Cranial is intended for use in cranial surgery to fixate MEDPOR cranial implants to the surrounding cranial skeleton.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101835 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101835: Medpor Fixation System-Cranial, Models 80080, 80079.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101835
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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