510(k) · Cleared
ClearedMemometal Anchorage Bone Plate System, Models PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Memometal Technologies · HRS Plate, Fixation, Bone
Cleared on Feb 6, 2009 as substantially equivalent to K061808 (Darco International, Inc., 2006) after a 77-day review. Its family tree reaches back 2 generations to 2002. 92 later devices descend from it.
- Decided
- Feb 6, 2009
- Review
- 77 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K022325 (2002). 92 later devices descend from it, 10 citing it directly.
- Root · 2 generations backK022325 Normed Titanium Osteotomy Plating SystemOsteomedics, Inc. · 2002 · Recalled
- 1 generation backK061808 Darco Locking Bone Plate SystemDarco International, Inc. · 2006 · Recalled
- This deviceK083447 Memometal Anchorage Bone Plate System, Models PLSS/PLSL…Memometal Technologies · 2009
- Descendant · cites it directly · 24 of its ownK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · Recalled
- Descendant · cites it directly · 23 of its ownK132594 Crosscheck Plating SystemSolana Surgical, LLC · 2013 · Recalled
- Descendant · 2 generations on · 22 of its ownK152974 ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc · 2015
- Descendant · cites it directly · 21 of its ownK163293 Colink™ Plating SystemIn2bones USA, LLC · 2017 · Recalled
- Descendant · 2 generations on · 16 of its ownK172300 CoLink View Plating SystemIn2bones USA, LLC · 2017
Showing 5 of 92 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 92 · See all- K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · cites it directly24descendants
- K132594Crosscheck Plating SystemSolana Surgical, LLC · 2013 · cites it directly23descendants
- K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc · 2015 · 2 generations on22descendants
- K163293Colink™ Plating SystemIn2bones USA, LLC · 2017 · cites it directly21descendants
- K172300CoLink View Plating SystemIn2bones USA, LLC · 2017 · 2 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022325 | Normed Titanium Osteotomy Plating System | Osteomedics, Inc. | 2002 | 1 |
| −1 | K061808 | Darco Locking Bone Plate System | Darco International, Inc. | 2006 | 3 |
| 0 (this device) | K083447 | Memometal Anchorage Bone Plate System, Models PLSS/PLSL… | Memometal Technologies | 2009 | — |
| +1 | K131722 | I.T.S. Extremity Fixation Systems | I.T.S. GmbH | 2013 | 2 |
| +1 | K132594 | Crosscheck Plating System | Solana Surgical, LLC | 2013 | 21 |
| +2 | K152974 | ORTHOLOC® 3Di Foot Plating Reconstruction System | Wrightmedicaltechnologyinc | 2015 | — |
| +1 | K163293 | Colink™ Plating System | In2bones USA, LLC | 2017 | 2 |
| +2 | K172300 | CoLink View Plating System | In2bones USA, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 7 | 0 |
| 2016 | 2 | 0 |
| 2017 | 7 | 0 |
| 2018 | 5 | 0 |
| 2019 | 6 | 0 |
| 2020 | 9 | 0 |
| 2021 | 8 | 0 |
| 2022 | 6 | 0 |
| 2023 | 12 | 0 |
| 2024 | 10 | 0 |
| 2025 | 5 | 0 |
| 2026 | 12 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K061808 | Darco Locking Bone Plate SystemSummary page 1…Bone Plate System Common Name Bone Osteosynthesis Bone Plates System Classification Name Plate, Fixation, Bone Legally marketed K061 808 DARCO locking bone plate system predicate devices Description MEMOMETAL ANCHORAGE® Bone Plate Systems are… | 2006 |
What descends from it? (92)
See all 9210 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131722 | I.T.S. Extremity Fixation Systems | 2013 | 24 |
| K132594 | Crosscheck Plating System | 2013 | 23 |
| K163293 | Colink™ Plating System | 2017 | 21 |
| K152306 | MotoBand¿ CP Implant System | 2015 | 7 |
| K160300 | MotoBand (TM) CP Implant System | 2016 | 6 |
| K161448 | Footmotion Plating System | 2016 | 5 |
| K172148 | Anchorage Bone Plating System | 2018 | 4 |
| K143523 | Airlock osteosynthesis plate system | 2015 | 4 |
| K151277 | Airlock® osteosynthesis plate system | 2015 | 2 |
| K200043 | Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws… | 2020 | 1 |
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 7 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K131722 (I.T.S. GmbH, 2013) has gone furthest, with 24 descendants of its own.
- 23 other devices also cite its predicate K061808.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The ANCHORAGE® Bone Plate System is indicated for stabilization and fixation of
fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of
the hand, feet, wrist and ankles, fingers and toes. The system may be used in both
adults and pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083447 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083447: Memometal Anchorage Bone Plate System, Models PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083447
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