510(k) · Cleared
ClearedApollo Ankle Fracture Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Glw Medical, Inc. · HRS Plate, Fixation, Bone
Cleared on Mar 11, 2022 as substantially equivalent to K163044 (Wrightmedicaltechnologyinc, 2017) after a 172-day review. Its family tree reaches back 4 generations to 2008. 1 later device descends from it.
- Decided
- Mar 11, 2022
- Review
- 172 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K082320 (2008). 7 ancestors in all, the oldest K000684 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK082320 Darco Small ScrewWrightmedicaltechnologyinc · 2008
- 3 generations backK102429 Ortholoc 3DI Ankle Plating System, Ortholoc Bone ScrewWrightmedicaltechnologyinc · 2010 · Recalled
- 2 generations backK131093 Ortholoc (R) 3DI Ankle Plating SystemWrightmedicaltechnologyinc · 2013
- 1 generation backK163044 ORTHOLOC® 3Di Ankle Fracture Plating SystemWrightmedicaltechnologyinc · 2017
- This deviceK213005 Apollo Ankle Fracture Plating SystemGlw Medical, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK221489 Artemis Proximal Femoral Nail SystemGlw, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K221489Artemis Proximal Femoral Nail SystemGlw, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K082320 | Darco Small Screw | Wrightmedicaltechnologyinc | 2008 | — |
| −3 | K102429 | Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw | Wrightmedicaltechnologyinc | 2010 | 1 |
| −2 | K131093 | Ortholoc (R) 3DI Ankle Plating System | Wrightmedicaltechnologyinc | 2013 | — |
| −1 | K163044 | ORTHOLOC® 3Di Ankle Fracture Plating System | Wrightmedicaltechnologyinc | 2017 | — |
| 0 (this device) | K213005 | Apollo Ankle Fracture Plating System | Glw Medical, Inc. | 2022 | — |
| +1 | K221489 | Artemis Proximal Femoral Nail System | Glw, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (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 |
|---|---|---|---|
| * | K163044 | ORTHOLOC® 3Di Ankle Fracture Plating SystemSummary page 5…21CFR 888.3040 Product Code HRS HWC Name of Primary Predicate 510(k) # Manufacturer Device Ortholoc 3Di Ankle Fracture K163044 Wright Medical System Name of Reference 510(k) # Manufacturer Device(s) In2Bones Colink View… | 2017 |
| † | K193543 | CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System… | 2020 |
| † | K200291 | CREED™ Cannulated Screws | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221489 | Artemis Proximal Femoral Nail System | 2022 | 0 |
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 14 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K221489 (Glw, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K163044.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Apollo™ Ankle Fracture Plating System is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula such as: » Lateral Malleolar Fractures » Syndesmosis Injuries » Medial Malleolar Fractures » Bi-Malleolar Fractures » Tri-Malleolar Fractures » Posterior Malleolar Fractures » Distal Anterior Tibia Fractures » Vertical Shear Fractures of the Medial Malleolus » Pilon Fractures » Distal Tibia Shaft Fractures » Distal…
Read the full statement (181 words)
Apollo™ Ankle Fracture Plating System is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula such as:
» Lateral Malleolar Fractures
» Syndesmosis Injuries
» Medial Malleolar Fractures
» Bi-Malleolar Fractures
» Tri-Malleolar Fractures
» Posterior Malleolar Fractures
» Distal Anterior Tibia Fractures
» Vertical Shear Fractures of the Medial Malleolus
» Pilon Fractures
» Distal Tibia Shaft Fractures
» Distal Fibula Shaft Fractures
» Distal Tibia Periarticular Fractures
» Medial Malleolar Avulsion Fractures
» Lateral Malleolar Avulsion Fractures
Apollo Locking Screws are intended for use with Apollo’s Plating Systems.
Apollo non-Locking Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
Apollo washer is intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of bone fragments.
Apollo 1/3 tubular plates are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213005 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213005: Apollo Ankle Fracture 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/K213005
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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