510(k) · Cleared
ClearedTwistcut Endosorb Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merete Medical GmbH · JDW Pin, Fixation, Threaded
Cleared on Dec 20, 2010 as substantially equivalent to K100414 (Merete Medical GmbH, 2010) and 1 other predicate after an 87-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Dec 20, 2010
- Review
- 87 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K011137 (2001). 4 ancestors in all, the oldest K992301 (1999). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011137 | Resorbable Hammertoe Pin | Biomet, Inc. | 2001 | — |
| −2 | K021828 | Small Hammer Toe Pin | Biomet, Inc. | 2002 | — |
| −1 | K100414 | Protoe Endosorb Small Hammer Toe Pin | Merete Medical GmbH | 2010 | — |
| 0 (this device) | K102777 | Twistcut Endosorb Screws | Merete Medical GmbH | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 JDW? 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 JDW device
- #1 K260073 XT3 System; XT3 System, Mini; XT3 System…score 15.0 · 15 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 |
|---|---|---|---|
| * | K100414 | Protoe Endosorb Small Hammer Toe PinSummary page 1…egulatory Class: Class 11 Legally Marketed Devices To Which Substantial Equivalence is Claimed: ProToe~m EndoSorb TM Small Hammer Toe Pin, Merete (K1 00414) Reunite Screws, Biomet (K992301) Intended Use: The TwistCuft m EndoSorb~m Bone Screws are indicated for use in the presence of… | 2010 |
| * | K992301 | Reunite ScrewsSummary page 1…Class 11 Legally Marketed Devices To Which Substantial Equivalence is Claimed: ProToe~m EndoSorb TM Small Hammer Toe Pin, Merete (K1 00414) Reunite Screws, Biomet (K992301) Intended Use: The TwistCuft m EndoSorb~m Bone Screws are indicated for use in the presence of appropriate immobilization in the… | 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 9 years and passes through 2 companies; a new generation was cleared every 1.0 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K100414.
How does its category compare?
All JDW devicesJDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · JDW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDW
Too few JDW 510(k)s in any year since 2007 to give a median.
Recalls per year · JDW
21in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDW
29in 2025
MAUDE reports naming product code JDW, 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 | 2 | — | 0 | 25 |
| 2008 | 0 | — | 0 | 26 |
| 2009 | 1 | — | 2 | 29 |
| 2010 | 2 | — | 2 | 29 |
| 2011 | 1 | — | 0 | 55 |
| 2012 | 1 | — | 52 | 75 |
| 2013 | 2 | — | 0 | 69 |
| 2014 | 2 | — | 0 | 27 |
| 2015 | 1 | — | 0 | 70 |
| 2016 | 0 | — | 0 | 46 |
| 2017 | 1 | — | 2 | 43 |
| 2018 | 1 | — | 21 | 94 |
| 2019 | 1 | — | 0 | 575 |
| 2020 | 2 | — | 0 | 402 |
| 2021 | 2 | — | 0 | 168 |
| 2022 | 2 | — | 0 | 121 |
| 2023 | 0 | — | 0 | 72 |
| 2024 | 0 | — | 0 | 65 |
| 2025 | 2 | — | 0 | 29 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The TwistCutM EndloSorbTM Bone Screws are indicated for use in the presence of appropriate immobilization in the following procedures:
1. for metacarpal and phalangeal fusion and fracture
2. or repair of hallux valgus deformity (bunion).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102777 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102777: Twistcut Endosorb Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102777
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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