510(k) · Cleared
ClearedBiomet Forerunner Locking Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Trauma (Aka Ebi, Lp) · HRS Plate, Fixation, Bone
Cleared on May 21, 2010 as substantially equivalent to K061808 (Darco International, Inc., 2006) and 2 other predicates after a 276-day review. Its family tree reaches back 2 generations to 2005. 53 later devices descend from it.
- Decided
- May 21, 2010
- Review
- 276 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K043059 (2005). 5 ancestors in all, the oldest K022325 (2002). 53 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK043059 Compression Staple and Simple StapleWrightmedicaltechnologyinc · 2005
- 1 generation backK051908 Charlotte Compression PlateWrightmedicaltechnologyinc · 2005
- This deviceK092528 Biomet Forerunner Locking Plate SystemBiomet Trauma (Aka Ebi, Lp) · 2010
- Descendant · cites it directly · 52 of its ownK113048 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- Descendant · 2 generations on · 39 of its ownK122005 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- Descendant · 3 generations on · 38 of its ownK123203 Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc. · 2012
- Descendant · 4 generations on · 32 of its ownK132591 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2013
- Descendant · 2 generations on · 25 of its ownK153379 AxSOS 3TiStryker GmbH · 2016
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K113048Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012 · cites it directly52descendants
- K122005Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012 · 2 generations on39descendants
- K123203Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc. · 2012 · 3 generations on38descendants
- K132591Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2013 · 4 generations on32descendants
- K153379AxSOS 3TiStryker GmbH · 2016 · 2 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K043059 | Compression Staple and Simple Staple | Wrightmedicaltechnologyinc | 2005 | — |
| −1 | K051908 | Charlotte Compression Plate | Wrightmedicaltechnologyinc | 2005 | — |
| 0 (this device) | K092528 | Biomet Forerunner Locking Plate System | Biomet Trauma (Aka Ebi, Lp) | 2010 | — |
| +1 | K113048 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| +2 | K122005 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| +3 | K123203 | Maxlock Extreme System Model MXL | Orthohelix Surgical Designs, Inc. | 2012 | — |
| +4 | K132591 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2013 | — |
| +2 | K153379 | AxSOS 3Ti | Stryker GmbH | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 9 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 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? (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 |
|---|---|---|---|
| * | K061808 | Darco Locking Bone Plate SystemSummary page 2…ss. Examples of predicate devices include: • DARCO Locked Universal Plate - marketed by Wright Medical Technology, Inc. - cleared under premarket notification K061808, * Charlotte Claw Compression Plate -marketed by Wright Medical Technology,lInc.- cleared under premarket notifications… | 2006 |
| * | K080295 | Charlotte Claw 3.5Summary page 2…ed under premarket notification K061808, * Charlotte Claw Compression Plate -marketed by Wright Medical Technology,lInc.- cleared under premarket notifications K080295 and K051908 Page 5-3… | 2008 |
| * | K051908 | Charlotte Compression PlateSummary page 2…market notification K061808, * Charlotte Claw Compression Plate -marketed by Wright Medical Technology,lInc.- cleared under premarket notifications K080295 and K051908 Page 5-3 DEPARTMEN… | 2005 |
What descends from it? (53)
See all 531 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113048 | Maxlock Extreme System | 2012 | 52 |
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 5 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K113048 (Orthohelix Surgical Designs, Inc., 2012) has gone furthest, with 52 descendants of its own.
- 23 other devices also cite its predicate K061808.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Biomet ForerunnerTM Plating System is used for adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, metacarpals, metatarsals, humerus, ulna, radius, middle hand, and middle foot bones. This 510(k) expands the indications for use…
Read the full statement (116 words)
The Biomet ForerunnerTM Plating System is used for adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, metacarpals, metatarsals, humerus, ulna, radius, middle hand, and middle foot bones. This 510(k) expands the indications for use to the forefoot, and adds specific indications for midfoot/forefoot procedures:
1. Treatment of fractures and fracture-dislocations of the midfoot/forefoot
2. Malunions
3. Non-unions
4. Joint fusions/arthrodesis
5. Corrective osteotomies for deformities
These procedures in the midfoot/forefoot may be indicated as a result of trauma, deformity, osteoarthritis, and rheumatoid arthritis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092528 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092528: Biomet Forerunner Locking Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092528
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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