510(k) · Cleared
Recalled · Class II · 2026Fibula Plate Prolock with Angular Stability
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I.T.S. Implantat-Technologie-Systeme GmbH · HRS Plate, Fixation, Bone
Cleared on Feb 2, 2007 as substantially equivalent to K000684 (Synthes (Usa), 2000) and 6 other predicates after a 53-day review. Its family tree reaches back 4 generations to 2000. 25 later devices descend from it. It has been recalled once.
- Decided
- Feb 2, 2007
- Review
- 53 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 8
Its longest line of descent runs back 4 generations to K000684 (2000). 23 ancestors in all, the oldest K890939 (1989). 25 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 3 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 2 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 1 generation backK033639 Acumed Lower Extremity Congruent Plate SystemAcumed, LLC · 2004 · Recalled
- This deviceK063672 Fibula Plate Prolock with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH · 2007
- Descendant · cites it directly · 19 of its ownK162674 BioPro Foot Plating SystemsBiopro, Inc. · 2017
- Descendant · 2 generations on · 11 of its ownK193222 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2020
- Descendant · 3 generations on · 10 of its ownK203817 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021
- Descendant · 3 generations on · 9 of its ownK222465 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2023
- Descendant · 2 generations on · 5 of its ownK183011 Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics · 2019
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K162674BioPro Foot Plating SystemsBiopro, Inc. · 2017 · cites it directly19descendants
- K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2020 · 2 generations on11descendants
- K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021 · 3 generations on10descendants
- K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2023 · 3 generations on9descendants
- K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics · 2019 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −3 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −2 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −1 | K033639 | Acumed Lower Extremity Congruent Plate System | Acumed, LLC | 2004 | 10 |
| 0 (this device) | K063672 | Fibula Plate Prolock with Angular Stability | I.T.S. Implantat-Technologie-Systeme GmbH | 2007 | — |
| +1 | K162674 | BioPro Foot Plating Systems | Biopro, Inc. | 2017 | — |
| +2 | K193222 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2020 | — |
| +3 | K203817 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2021 | — |
| +3 | K222465 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2023 | — |
| +2 | K183011 | Additive Orthopaedics Patient Specific 3D Locking Lattice Plates | Additive Orthopaedics | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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? (9)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 1…VICE PRODUCT CODE: FIRS SUBSTANTIALLY Synthes Semi-Tubular Plate (Pre - Amendment) EQUIVALENT DEVICES Synthes Small Fragment System (K000684) Synthes 4.5mm LCP Straight Reconstruction Plates (K051986) Synthes LCP Distal… | 2000 |
| * | K051986 | Synthes 4.5 MM LCP Straight Reconstruction PlatesSummary page 1…bular Plate (Pre - Amendment) EQUIVALENT DEVICES Synthes Small Fragment System (K000684) Synthes 4.5mm LCP Straight Reconstruction Plates (K051986) Synthes LCP Distal Tibia Plates (K013248) Synthes One-Third Tubular DCL Plate… | 2005 |
| * | K013248 | Synthes LCP Distal Tibia PlatesSummary page 1…l Fragment System (K000684) Synthes 4.5mm LCP Straight Reconstruction Plates (K051986) Synthes LCP Distal Tibia Plates (K013248) Synthes One-Third Tubular DCL Plate (K011335) Synthes Curved Reconstruction Pl… | 2001 |
| * | K011335 | Synths One-Third Tubular DCL PlateSummary page 1…Straight Reconstruction Plates (K051986) Synthes LCP Distal Tibia Plates (K013248) Synthes One-Third Tubular DCL Plate (K011335) Synthes Curved Reconstruction Plate (K1011334) Synthes Medial Distal Tibia Pla… | 2001 |
| Kept off the family tree | K010334 | FDA’s K010334 is Wako Lipid Calibrator Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2001 |
| * | K001945 | Synthes (Usa) Medial Distal Tibia PlatesSummary page 1…ne-Third Tubular DCL Plate (K011335) Synthes Curved Reconstruction Plate (K1011334) Synthes Medial Distal Tibia Plates (K001945) Zimmer Periarticular Plating System (K040593) Acumed Lower Extremity Congruent… | 2000 |
| * | K040593 | Periarticular Locking Plates and Screws, 2358, 2359 SeriesSummary page 1…urved Reconstruction Plate (K1011334) Synthes Medial Distal Tibia Plates (K001945) Zimmer Periarticular Plating System (K040593) Acumed Lower Extremity Congruent Plate System (K033639) DEVICE DESCRIPTION: The LT.S. Fibula Plate… | 2004 |
| * | K033639 | Acumed Lower Extremity Congruent Plate SystemSummary page 1…tal Tibia Plates (K001945) Zimmer Periarticular Plating System (K040593) Acumed Lower Extremity Congruent Plate System (K033639) DEVICE DESCRIPTION: The LT.S. Fibula Plate PROlock with Angular Stability is a low-profile left an… | 2004 |
| * | — | Synthes Semi-Tubular Plate (Pre-Amendment) Named without a submission number |
What descends from it? (25)
See all 253 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 |
|---|---|---|---|---|
| Jan 23, 2026 | Class II | Z-1601-2026 | No Marketing Application | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 8 of the 23 ancestors have a recall of any class.
- Of its descendants, K162674 (Biopro, Inc., 2017) has gone furthest, with 19 descendants of its own.
- 68 other devices also cite its predicate K000684.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 I.T.S. Fibula Plate PROlock with Angular Stability is a titanium implant fracture fixation system for repairing bone fractures located from the middle to the distal third of the fibula.
Indications for Use include metaphysial and diaphysial fracture fixation of acute fractures, malunions, and non-unions of the distal fibula. Other indications include corrective osteotomy and open and closed fractures.
The system is not intended for spinal use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063672 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063672: Fibula Plate Prolock with Angular Stability.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063672
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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