510(k) · Cleared
ClearedExtrimilock Ankle Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed LP · HRS Plate, Fixation, Bone
Cleared on Feb 24, 2014 as substantially equivalent to K011335 (Synthes (Usa), 2001) and 3 other predicates after an 84-day review. Its family tree reaches back 8 generations to 1998. 10 later devices descend from it.
- Decided
- Feb 24, 2014
- Review
- 84 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K981372 (1998). 25 ancestors in all, the oldest K954330 (1995). 10 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 7 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 6 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- 5 generations backK050457 Merete Metafix Small Fragment Bone Plate SystemMerete Medical GmbH · 2005
- 4 generations backK063487 Merete BLP Small Fragment Locking Bone PlateMerete Medical GmbH · 2007
- 3 generations backK081513 Merete 3.0 and 3.5 MM Locking ScrewsMerete Medical GmbH · 2008
- 2 generations backK090063 Merete Locking Bone Plate SystemMerete Medical, Inc. · 2009
- 1 generation backK120787 Merete Locking Bone Plate System IiiMerete Medical GmbH · 2012
- This deviceK133691 Extrimilock Ankle Plating SystemOsteomed LP · 2014
- Descendant · cites it directly · 5 of its ownK160191 Align Anterior Ankle Fusion PlateExtremity Medical, LLC · 2016
- Descendant · cites it directly · 4 of its ownK181067 AlignX Ankle Fusion SystemExtremity Medical, LLC · 2018
- Descendant · cites it directly · 2 of its ownK173121 Ankle Fusion Plating SystemIn2bones Sas · 2017
- Descendant · 2 generations on · 1 of its ownK231887 ARIX Ankle Distal Tibia SystemJeil Medical Corporation · 2023
- Descendant · 2 generations on · 1 of its ownK213069 CoLink NeoFuse Plating SystemIn2bones USA, LLC · 2021
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC · 2016 · cites it directly5descendants
- K181067AlignX Ankle Fusion SystemExtremity Medical, LLC · 2018 · cites it directly4descendants
- K173121Ankle Fusion Plating SystemIn2bones Sas · 2017 · cites it directly2descendants
- K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation · 2023 · 2 generations on1descendant
- K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −7 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −6 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| −5 | K050457 | Merete Metafix Small Fragment Bone Plate System | Merete Medical GmbH | 2005 | — |
| −4 | K063487 | Merete BLP Small Fragment Locking Bone Plate | Merete Medical GmbH | 2007 | — |
| −3 | K081513 | Merete 3.0 and 3.5 MM Locking Screws | Merete Medical GmbH | 2008 | — |
| −2 | K090063 | Merete Locking Bone Plate System | Merete Medical, Inc. | 2009 | — |
| −1 | K120787 | Merete Locking Bone Plate System Iii | Merete Medical GmbH | 2012 | — |
| 0 (this device) | K133691 | Extrimilock Ankle Plating System | Osteomed LP | 2014 | — |
| +1 | K160191 | Align Anterior Ankle Fusion Plate | Extremity Medical, LLC | 2016 | — |
| +1 | K181067 | AlignX Ankle Fusion System | Extremity Medical, LLC | 2018 | — |
| +1 | K173121 | Ankle Fusion Plating System | In2bones Sas | 2017 | — |
| +2 | K231887 | ARIX Ankle Distal Tibia System | Jeil Medical Corporation | 2023 | — |
| +2 | K213069 | CoLink NeoFuse Plating System | In2bones USA, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 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? (4)
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 |
|---|---|---|---|
| * | K011335 | Synths One-Third Tubular DCL PlateSummary page 1…o HWC Device Class: 11 Predicate Devices: Synthes Dynamic Compression Locking Plating System (Synthes One-Third Tubular DCL Plate). K01 1335 Classification Name: Single/multiple component metallic bone fixation appliances and ac… | 2001 |
| * | K091614 | Osteomed Foot Plating SystemSummary page 1…on appliances and accessories (2ICFR 888.3030, Product Code HIRS) Device Class: 11 OsteoMed Foot Plating System. K091 614 Classification Name: Single/multiple component metallic bone fixation appliances and ac… | 2009 |
| * | K954330 | Super Screw 3.5 MMSummary page 2…EAPS Page 85 of 440 K133691 (P9 2/3) OsteoMed Super Screw 3.5mm. K954330 Classification Name: Smooth or threaded metallic bone fixation fastener (21 CFR 888.… | 1995 |
| * | K120787 | Merete Locking Bone Plate System IiiSummary page 2…ixation fastener (21 CFR 888.3040, Product Code HWC) Device Class: 11 Merete Locking Bone Plate System Ill. K120787 Classification Name: Single/multiple component metallic bone fixation appliances and… | 2012 |
What descends from it? (10)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 5 of the 25 ancestors have a recall of any class.
- Of its descendants, K160191 (Extremity Medical, LLC, 2016) has gone furthest, with 5 descendants of its own.
- 42 other devices also cite its predicate K011335.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 OsteoMed ExtremiLOCK Ankle Plating System is intended for fixation of fractures, arthrodesis, osteotomies, and non-unions of the tibia and fibula. The ExtremiLOCK Ankle Plating System implants are intended for single use only.
The 1/3 tubular plates, hook plates, screws, and washers are also intended for use in trauma, general surgery, and reconstructive procedures of bones appropriate for the size of the device.
The OsteoMed ExtremiLOCK Ankle Plating System can be used for adult and pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133691 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133691: Extrimilock Ankle Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133691
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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