510(k) · Cleared
Recalled · Class II · 2019Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Normed Medizin-Technik GmbH · HRS Plate, Fixation, Bone
Cleared on Aug 2, 2013 as substantially equivalent to K022324 (Osteomedics, Inc., 2002) and 2 other predicates after a 275-day review. Its family tree reaches back 11 generations to 2001. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 2, 2013
- Review
- 275 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 11 generations to K010612 (2001). 92 ancestors in all, the oldest K792022 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 7 generations between
- 3 generations backK092497 Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009
- 2 generations backK100107 Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · Recalled
- 1 generation backK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
- This deviceK123347 Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH · 2013
- Descendant · cites it directly · 0 of its ownK212640 Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK203479 ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed · 2021
Show all 11 generations
- Root · 11 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 10 generations backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
- 9 generations backK040368 Vectorvision Hip 3.0Brainlab AG · 2004
- 8 generations backK052213 Navigation SW Hip 3.1 on CIBrainlab AG · 2005
- 7 generations backK060468 Vectorvision HipBrainlab AG · 2006
- 6 generations backK070731 Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG · 2007
- 5 generations backK080875 Pigalileo 4TH Generation SystemSmith & Nephew, Inc. · 2008
- 4 generations backK090420 Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc. · 2009
- 3 generations backK092497 Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009
- 2 generations backK100107 Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · Recalled
- 1 generation backK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
- This deviceK123347 Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| −10 | K021306 | Vectorvision CT-Free Knee | Brainlab AG | 2002 | — |
| −9 | K040368 | Vectorvision Hip 3.0 | Brainlab AG | 2004 | — |
| −8 | K052213 | Navigation SW Hip 3.1 on CI | Brainlab AG | 2005 | — |
| −7 | K060468 | Vectorvision Hip | Brainlab AG | 2006 | — |
| −6 | K070731 | Pigalileo Total Hip Replacement (THR) System | Plus Orthopedics AG | 2007 | — |
| −5 | K080875 | Pigalileo 4TH Generation System | Smith & Nephew, Inc. | 2008 | — |
| −4 | K090420 | Smith & Nephew Pigalileo Screw Targeting System V 1.0 | Smith & Nephew, Inc. | 2009 | — |
| −3 | K092497 | Smith & Nephew Pigalileo Screw Targeting System, Version 1.1 | Smith & Nephew, Inc. | 2009 | — |
| −2 | K100107 | Smith & Nephew Sureshot Distal Targeting System V2.0 | Smith & Nephew, Inc. | 2010 | 1 |
| −1 | K110670 | VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone… | Smith & Nephew, Inc. | 2011 | — |
| 0 (this device) | K123347 | Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0 | Normed Medizin-Technik GmbH | 2013 | — |
| +1 | K212640 | Stratum® Ankle Fusion Plating System | Nextremity Solutions, Inc. | 2021 | — |
| +1 | 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 | 2 | 0 |
| 1996 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 11 | 0 |
| 2002 | 11 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 6 | 0 |
| 2006 | 7 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K022324 | Normed Titanium Calcaneus Plating with Locking Screw SystemSummary page 1…allic bone fixation fastener Predicate Device: Normed Titanium Calcaneus Plating with Locking Screw System - K022324, cleared 9/17/02… | 2002 |
| * | K110670 | VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Summary page 2…Bone Plates, VLP Bone Screws; Peri-Loc Ankle Fusion Bone Plates and Instruments - Ki 110670, cleared 7/12/11 Ascension Ankle Fusion Plate System -… | 2011 |
| * | K100176 | Ascension Ankle Fusion Plate SystemSummary page 2…Instruments - Ki 110670, cleared 7/12/11 Ascension Ankle Fusion Plate System - K 100 176, cleared 6/16/10 Device Description: The Normed ANKLE FIX and ANKLE FIX… | 2010 |
What descends from it? (2)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 8, 2019 | Class II | Z-1433-2019 | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. |
| Apr 8, 2019 | Class II | Z-1451-2019 | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 21 of the 92 ancestors have a recall of any class.
- Of its descendants, K212640 (Nextremity Solutions, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K022324.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
ANKLE FIX and ANKLE FIX + Systems 4.0 are indicated for:
skeletal osteosynthesis of small bone fragments, which were damaged due to trauma or require reconstruction or arthrodesis
primary or revision tibio-talar and tibiotalo-calcaneal fusion especially in the presence of osteopenic bone, hindfoot deformity and bone loss
post-traumatic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123347 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123347: Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123347
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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