510(k) · Cleared
ClearedExtremiLOCK Lateral Ankle Fusion Plates
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed · HRS Plate, Fixation, Bone
Cleared on Feb 24, 2021 as substantially equivalent to K123347 (Normed Medizin-Technik GmbH, 2013) and 1 other predicate after an 89-day review. Its family tree reaches back 12 generations to 2001.
- Decided
- Feb 24, 2021
- Review
- 89 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K010612 (2001). 109 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 12 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 8 generations between
- 3 generations backK100107 Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · Recalled
- 2 generations backK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
- 1 generation backK123347 Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH · 2013 · Recalled
- This deviceK203479 ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed · 2021
Show all 12 generations
- Root · 12 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 11 generations backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
- 10 generations backK040368 Vectorvision Hip 3.0Brainlab AG · 2004
- 9 generations backK052213 Navigation SW Hip 3.1 on CIBrainlab AG · 2005
- 8 generations backK060468 Vectorvision HipBrainlab AG · 2006
- 7 generations backK070731 Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG · 2007
- 6 generations backK080875 Pigalileo 4TH Generation SystemSmith & Nephew, Inc. · 2008
- 5 generations backK090420 Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc. · 2009
- 4 generations backK092497 Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009
- 3 generations backK100107 Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · Recalled
- 2 generations backK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
- 1 generation backK123347 Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH · 2013 · Recalled
- This deviceK203479 ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| −11 | K021306 | Vectorvision CT-Free Knee | Brainlab AG | 2002 | — |
| −10 | K040368 | Vectorvision Hip 3.0 | Brainlab AG | 2004 | — |
| −9 | K052213 | Navigation SW Hip 3.1 on CI | Brainlab AG | 2005 | — |
| −8 | K060468 | Vectorvision Hip | Brainlab AG | 2006 | — |
| −7 | K070731 | Pigalileo Total Hip Replacement (THR) System | Plus Orthopedics AG | 2007 | — |
| −6 | K080875 | Pigalileo 4TH Generation System | Smith & Nephew, Inc. | 2008 | — |
| −5 | K090420 | Smith & Nephew Pigalileo Screw Targeting System V 1.0 | Smith & Nephew, Inc. | 2009 | — |
| −4 | K092497 | Smith & Nephew Pigalileo Screw Targeting System, Version 1.1 | Smith & Nephew, Inc. | 2009 | — |
| −3 | K100107 | Smith & Nephew Sureshot Distal Targeting System V2.0 | Smith & Nephew, Inc. | 2010 | 1 |
| −2 | K110670 | VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone… | Smith & Nephew, Inc. | 2011 | — |
| −1 | K123347 | Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0 | Normed Medizin-Technik GmbH | 2013 | 2 |
| 0 (this device) | K203479 | ExtremiLOCK Lateral Ankle Fusion Plates | Osteomed | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1998 | 6 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 11 | 0 |
| 2002 | 12 | 0 |
| 2003 | 5 | 0 |
| 2004 | 4 | 0 |
| 2005 | 8 | 0 |
| 2006 | 8 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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? (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 |
|---|---|---|---|
| * | K123347 | Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Summary page 4…egulatory Class: II Product Code: HRS (Primary) & HWC & HTN III. PREDICATE DEVICES Predicate Device: Normed/Zimmer Ankle Fix 4.0, K123347 Additional Predicate: OsteoMed ExtremiLOCK Ankle Plating System, K133691 IV. DEVICE DESCRIPTION The OsteoMed… | 2013 |
| * | K133691 | Extrimilock Ankle Plating SystemSummary page 4…C & HTN III. PREDICATE DEVICES Predicate Device: Normed/Zimmer Ankle Fix 4.0, K123347 Additional Predicate: OsteoMed ExtremiLOCK Ankle Plating System, K133691 IV. DEVICE DESCRIPTION The OsteoMed ExtremiLOCK Lateral Ankle Fusion Plates are a line extension to be include… | 2014 |
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 1.2 years on median.
- 24 of the 109 ancestors have a recall of any class.
- 1 other device also cites its predicate K123347.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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, osteotomies, and non-unions of the tibia and fibula as well as arthrodesis of the ankle including Tibiotalar and Tibiotalocalcaneal joint. 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 adolescent (greater than 12-21 years of age) patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203479 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203479: ExtremiLOCK Lateral Ankle Fusion Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203479
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