510(k) · Cleared
ClearedAesculap Resorbable Pin, Model FR735
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Implant System, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Apr 30, 2007 as substantially equivalent to K983577 (Arthrex, Inc., 1999) and 1 other predicate after a 101-day review. Its family tree reaches back 2 generations to 1987.
- Decided
- Apr 30, 2007
- Review
- 101 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K864912 (1987). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK864912 PDS (Polydioxanon) Absorbable PinJohnson & Johnson Professionals, Inc. · 1987
- 1 generation backK993074 Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525Bionx Implants, Ltd. · 1999
- This deviceK070178 Aesculap Resorbable Pin, Model FR735Aesculap Implant System, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864912 | PDS (Polydioxanon) Absorbable Pin | Johnson & Johnson Professionals, Inc. | 1987 | — |
| −1 | K993074 | Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525 | Bionx Implants, Ltd. | 1999 | — |
| 0 (this device) | K070178 | Aesculap Resorbable Pin, Model FR735 | Aesculap Implant System, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K983577 | Arthrex Meniscal Dart SystemSummary page 1…ap Implant Systems, Inc. believes that the Aesculap® Resorbable Pin is equivalent in materials and similar in use to the previously cleared Arthrex Meniscal Dart System (K983577) and the Bionx Smart Nail from ConMed Linvatec (K993074). DEPARTMENT OF HEALTH & HUMAN SERVICES… | 1999 |
| * | K993074 | Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525Summary page 1…orbable Pin is equivalent in materials and similar in use to the previously cleared Arthrex Meniscal Dart System (K983577) and the Bionx Smart Nail from ConMed Linvatec (K993074). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 1999 |
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 3 companies; a new generation was cleared every 12.4 years on median.
- None of the 7 ancestors has a recall.
- 3 other devices also cite its predicate K983577.
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
The Aesculap Resorbable Pin is intended for use in the fixation of fragments of non-load bearing bones, osteotomies, arthrodeses, meniscal tissue repair, and osteochondral repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070178 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070178: Aesculap Resorbable Pin, Model FR735.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070178
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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