510(k) · Cleared
ClearedMaxlock Extreme Elbow Fracture System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthohelix Surgical Designs, Inc. · HRS Plate, Fixation, Bone
Cleared on Jul 11, 2014 as substantially equivalent to K123203 (Orthohelix Surgical Designs, Inc., 2012) and 5 other predicates after a 53-day review. Its family tree reaches back 12 generations to 1996.
- Decided
- Jul 11, 2014
- Review
- 53 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 12 generations to K954385 (1996). 66 ancestors in all, the oldest K885250 (1989). No later device cites it as a predicate yet.
- Root · 12 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 8 generations between
- 3 generations backK113048 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 2 generations backK122005 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 1 generation backK123203 Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc. · 2012
- This deviceK141301 Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc. · 2014
Show all 12 generations
- Root · 12 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 11 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 10 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 9 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 8 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 7 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 6 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 5 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 4 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 3 generations backK113048 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 2 generations backK122005 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 1 generation backK123203 Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc. · 2012
- This deviceK141301 Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −11 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −10 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −9 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −8 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −7 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −6 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −5 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −4 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −3 | K113048 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −2 | K122005 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −1 | K123203 | Maxlock Extreme System Model MXL | Orthohelix Surgical Designs, Inc. | 2012 | — |
| 0 (this device) | K141301 | Maxlock Extreme Elbow Fracture System | Orthohelix Surgical Designs, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 6 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 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? (6)
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 |
|---|---|---|---|
| * | K123203 | Maxlock Extreme System Model MXLSummary page 1…TM existing OrthoHetix MaxL-ock Extreme System, Universal Module (K123203) as well as Stryker VariAx Elbow System (K073527, K092433 &… | 2012 |
| * | K073527 | Variax Elbow SystemSummary page 1…existing OrthoHetix MaxL-ock Extreme System, Universal Module (K123203) as well as Stryker VariAx Elbow System (K073527, K092433 & 5-1 === Page 2 =… | 2008 |
| * | K093433 | Variax Elbow System Plate Line Extension Our reading of the summary gave K092433, FDA’s number for DYSIS (Forth Photonics Hellas SA). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Stryker VariAx Elbow System”. | 2010 |
| * | K101056 | Variax Elbow SystemSummary page 2…5-1 K141301 page 2 of 2 (101056) the Depuy Orthopaedics, Anatomic Locking Plating System (1(082300) and the Acumed Congruent Bone Plating System (1(012655). Fini… | 2010 |
| * | K082300 | Anatomic Locking Plating SystemSummary page 2…5-1 K141301 page 2 of 2 (101056) the Depuy Orthopaedics, Anatomic Locking Plating System (1(082300) and the Acumed Congruent Bone Plating System (1(012655). Finite element analysis was performed on the subject plating device and… | 2009 |
| * | K012655 | Congruent Bone Plate SystemSummary page 2…K141301 page 2 of 2 (101056) the Depuy Orthopaedics, Anatomic Locking Plating System (1(082300) and the Acumed Congruent Bone Plating System (1(012655). Finite element analysis was performed on the subject plating device and the predicate device to determine the worst case implan… | 2001 |
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 18 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 15 of the 66 ancestors have a recall of any class.
- 2 other devices also cite its predicate K123203.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 MaxLock Extreme System is indicated for the following: *The MaxLock Extreme Universal Module is indicated for use in 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, humerus, ulna, radius, and bones in the hand, wrist, foot…
Read the full statement (141 words)
The MaxLock Extreme System is indicated for the following:
*The MaxLock Extreme Universal Module is indicated for use in 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, humerus, ulna, radius, and bones in the hand, wrist, foot and ankle.
*The MaxLock Extreme Clavicle Module is indicated for fractures, fusions and osteotomies of the clavicle and bones in the hand, wrist, foot and ankle.
*The MaxLock Extreme Foot Module is indicated for fractures, fusions and osteotomies of bones in the hand, wrist, foot and ankle in pediatric and adult patients.
*The MaxLock Extreme Distal Radius Module is indicated for fractures and osteotomies of the distal radius in adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141301 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141301: Maxlock Extreme Elbow Fracture System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141301
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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