510(k) · Cleared
ClearedKLS Martin Oral-Max Implants MR Conditional (bundled)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KLS-Martin L.P. · JEY Plate, Bone
Cleared on Aug 16, 2024 as substantially equivalent to K943347 (Patton, Boggs & Blow, 1994) and 12 other predicates after a 98-day review. Its family tree reaches back 7 generations to 1990. 1 later device descends from it.
- Decided
- Aug 16, 2024
- Review
- 98 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 13
Its longest line of descent runs back 7 generations to K904436 (1990). 73 ancestors in all, the oldest K820944 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 6 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 5 generations backK972783 Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc. · 1998
- 4 generations backK982139 Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998
- 3 generations backK993061 Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999
- 2 generations backK011590 Resorb-X Resorbable Plating SystemKLS-Martin L.P. · 2002
- 1 generation backK060177 KLS Martin Rigid Fixation - SterileKLS Martin L.P. · 2006
- This deviceK241314 KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P. · 2024
- Descendant · cites it directly · 0 of its ownK260137 KLS Martin IPS Oral-Max Implants - MR Conditional; Individual…KLS-Martin L.P. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…KLS-Martin L.P. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −6 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −5 | K972783 | Biofix Biodegradable Threaded Suture Anchor | Bionx Implants, Inc. | 1998 | — |
| −4 | K982139 | Biosorbfx 1.5/2.0 Bioabsorbable Fixation System | Bionx Implants, Inc. | 1998 | — |
| −3 | K993061 | Stryker Leibinger Resorbable Fixation System | Stryker Instruments | 1999 | — |
| −2 | K011590 | Resorb-X Resorbable Plating System | KLS-Martin L.P. | 2002 | — |
| −1 | K060177 | KLS Martin Rigid Fixation - Sterile | KLS Martin L.P. | 2006 | — |
| 0 (this device) | K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled) | KLS-Martin L.P. | 2024 | — |
| +1 | K260137 | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient… | KLS-Martin L.P. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 5 | 0 |
| 1994 | 7 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 5 | 0 |
| 1998 | 7 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 JEY? 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 JEY device
- #1 K252246 Leforte MMF Systemscore 15.6 · 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? (13)
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 |
|---|---|---|---|
| * | K943347 | KLS Mini Osteosynthesis SystemSummary page 4…ation Date: 07/31/2026 Indications for Use See PRA Statement below. Submission Number (if known) K241314 Device Name KLS Martin Oral-Max Implants - MR Conditional; K943347: KLS Mini Osteosynthesis System; K943348: KLS Chin Plate System; K944561: KLS-Martin Micro Osteosynthesis System (1.0MM); K9445… | 1994 |
| * | K943348 | KLS Chin Plate SystemSummary page 4…e See PRA Statement below. Submission Number (if known) K241314 Device Name KLS Martin Oral-Max Implants - MR Conditional; K943347: KLS Mini Osteosynthesis System; K943348: KLS Chin Plate System; K944561: KLS-Martin Micro Osteosynthesis System (1.0MM); K944565: KLS-Martin Micro Osteosynthesis System… | 1994 |
| * | K944561 | Micro Osteosynthesis System (1.0)Summary page 4…ssion Number (if known) K241314 Device Name KLS Martin Oral-Max Implants - MR Conditional; K943347: KLS Mini Osteosynthesis System; K943348: KLS Chin Plate System; K944561: KLS-Martin Micro Osteosynthesis System (1.0MM); K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Cen… | 1994 |
| * | K944565 | KLS-Martin Micro Osteosythesis System (1.5MM)Summary page 4…Oral-Max Implants - MR Conditional; K943347: KLS Mini Osteosynthesis System; K943348: KLS Chin Plate System; K944561: KLS-Martin Micro Osteosynthesis System (1.0MM); K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K990667: KLS-Martin Temporary… | 1994 |
| * | K971297 | Centre-Drive Drill-Free ScrewSummary page 4…steosynthesis System; K943348: KLS Chin Plate System; K944561: KLS-Martin Micro Osteosynthesis System (1.0MM); K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K990667: KLS-Martin Temporary Condylar Implant; K032442: KLS-Martin Mandibular/Reconst… | 1997 |
| * | K990667 | KLS-Martin Temporary Condylar ImplantSummary page 4…em; K944561: KLS-Martin Micro Osteosynthesis System (1.0MM); K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K990667: KLS-Martin Temporary Condylar Implant; K032442: KLS-Martin Mandibular/Reconstruction System II; K033483: KLS-Martin Ortho Anchor… | 2001 |
| * | K032442 | KLS-Martin Mandibular/Reconstruction System IISummary page 4…stem (1.0MM); K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K990667: KLS-Martin Temporary Condylar Implant; K032442: KLS-Martin Mandibular/Reconstruction System II; K033483: KLS-Martin Ortho Anchorage System; K040891: KLS-Martin Ortho Anchorage… | 2003 |
| * | K033483 | KLS-Martin Ortho Anchorage SystemSummary page 4…stem (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K990667: KLS-Martin Temporary Condylar Implant; K032442: KLS-Martin Mandibular/Reconstruction System II; K033483: KLS-Martin Ortho Anchorage System; K040891: KLS-Martin Ortho Anchorage System (Plates); K060177: KLS Martin Rigid Fixation - St… | 2004 |
| * | K040891 | KLS Martin Ortho Anchorage System (Plates)Summary page 4…e Drill-Free Screw; K990667: KLS-Martin Temporary Condylar Implant; K032442: KLS-Martin Mandibular/Reconstruction System II; K033483: KLS-Martin Ortho Anchorage System; K040891: KLS-Martin Ortho Anchorage System (Plates); K060177: KLS Martin Rigid Fixation - Sterile; K042573: KLS Martin Drill-Free MMF Sc… | 2004 |
| * | K060177 | KLS Martin Rigid Fixation - SterileSummary page 4…dylar Implant; K032442: KLS-Martin Mandibular/Reconstruction System II; K033483: KLS-Martin Ortho Anchorage System; K040891: KLS-Martin Ortho Anchorage System (Plates); K060177: KLS Martin Rigid Fixation - Sterile; K042573: KLS Martin Drill-Free MMF Screw; K083432: Drill Free MMF Screw; K173320: KLS Ma… | 2006 |
| * | K042573 | KLS Martin Drill-Free MMF ScrewSummary page 4…econstruction System II; K033483: KLS-Martin Ortho Anchorage System; K040891: KLS-Martin Ortho Anchorage System (Plates); K060177: KLS Martin Rigid Fixation - Sterile; K042573: KLS Martin Drill-Free MMF Screw; K083432: Drill Free MMF Screw; K173320: KLS Martin L1 MMF System Indications for Use (Descri… | 2004 |
| * | K083432 | Drill Free MMF ScrewSummary page 4…n Ortho Anchorage System; K040891: KLS-Martin Ortho Anchorage System (Plates); K060177: KLS Martin Rigid Fixation - Sterile; K042573: KLS Martin Drill-Free MMF Screw; K083432: Drill Free MMF Screw; K173320: KLS Martin L1 MMF System Indications for Use (Describe) KLS Mini Osteosynthesis System (K94334… | 2009 |
| * | K173320 | KLS Martin L1 MMF SystemSummary page 4…91: KLS-Martin Ortho Anchorage System (Plates); K060177: KLS Martin Rigid Fixation - Sterile; K042573: KLS Martin Drill-Free MMF Screw; K083432: Drill Free MMF Screw; K173320: KLS Martin L1 MMF System Indications for Use (Describe) KLS Mini Osteosynthesis System (K943347): The KLS Mini Osteosynthesis… | 2018 |
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 |
|---|---|---|---|
| K260137 | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti… | 2026 | 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 34 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 73 ancestors have a recall of any class.
- Of its descendants, K260137 (KLS-Martin L.P., 2026) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K943347.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · JEY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JEY
159in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JEY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEY
1,003in 2025
MAUDE reports naming product code JEY, 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 | 9 | 115 | 0 | 29 |
| 2008 | 7 | 84 | 3 | 24 |
| 2009 | 4 | 121 | 6 | 93 |
| 2010 | 6 | 199 | 85 | 215 |
| 2011 | 5 | 75 | 0 | 241 |
| 2012 | 10 | 194 | 0 | 428 |
| 2013 | 8 | 126 | 1 | 766 |
| 2014 | 6 | 223 | 0 | 616 |
| 2015 | 7 | 160 | 0 | 767 |
| 2016 | 1 | — | 0 | 558 |
| 2017 | 5 | 190 | 0 | 568 |
| 2018 | 7 | 255 | 0 | 608 |
| 2019 | 6 | 163 | 0 | 595 |
| 2020 | 6 | 198 | 1 | 680 |
| 2021 | 4 | 299 | 0 | 451 |
| 2022 | 5 | 135 | 0 | 344 |
| 2023 | 2 | — | 0 | 495 |
| 2024 | 5 | 159 | 0 | 696 |
| 2025 | 2 | — | 0 | 1,003 |
| 2026 | 3 | 258 | 0 | — |
What is it indicated for?
KLS Mini Osteosynthesis System (K943347): The KLS Mini Osteosynthesis System is indicated for 1) Fractures, 2) Osteotomies, 3) Reconstruction procedures of the craniomaxillofacial skeletal system. KLS Chin Plate System (K943348): The KLS Chin Plate System is indicated for 1) Fractures, 2) Osteotomies, 3) Reconstruction procedures of the craniomaxillofacial skeletal system. KLS-Martin Micro Osteosynthesis System (1.0MM) (K944561): The KLS-Martin Micro…
Read the full statement (652 words)
KLS Mini Osteosynthesis System (K943347):
The KLS Mini Osteosynthesis System is indicated for 1) Fractures, 2) Osteotomies, 3) Reconstruction procedures of the craniomaxillofacial skeletal system.
KLS Chin Plate System (K943348):
The KLS Chin Plate System is indicated for 1) Fractures, 2) Osteotomies, 3) Reconstruction procedures of the craniomaxillofacial skeletal system.
KLS-Martin Micro Osteosynthesis System (1.0MM) (K944561):
The KLS-Martin Micro Osteosynthesis System (1.0MM) is used in oral-maxillo-cranio-facial surgery to stabilize fractured bone structures. The bone segments are attached to the plate with screws to prevent movement of the segments.
KLS-Martin Micro Osteosynthesis System (1.5MM) (K944565):
The KLS-Martin Micro Osteosynthesis System (1.5MM) is used in oral-maxillo-cranio-facial surgery to stabilize fractured bone structures. The bone segments are attached to the plate with screws to prevent movement of the segments.
KLS Martin Centre-Drive Drill-Free Screw (K971297):
The KLS Martin Centre-Drive Drill-Free Screws are intended for use in rigid internal fixation of the oral-maxillo-cranio-facial bones. The bone screws are used to anchor plates which are contoured to fit the bony surface and stabilize the bone fragments. The addition of the self drilling feature is the only difference between the submitted device and the predicate device referenced.
KLS-Martin Temporary Condylar Implant (K990667):
The KLS-Martin Temporary Condylar Implant is only intended for temporary reconstruction of the mandibular condyle in patients who have undergone resective procedures to remove malignant or benign tumors requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMF or traumatic injuries, or for treatment of temporomandibular joint disease (I MD).
KLS-Martin Mandibular/Reconstruction System Il (K032442):
The KLS-Martin Mandibular/Reconstruction System Il is intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction.
KLS-Martin Ortho Anchorage System (K033483):
The KLS-Martin Ortho Anchorage System is intended to be surgically placed in the mouth for use an an anchor for orthodontic procedures.
KLS-Martin Ortho Anchorage System (Plates) (K040891):
The KLS-Martin Ortho Anchorage System (Plates) are implants intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures in patients.
KLS Martin Rigid Fixation - Sterile (K060177):
The KLS Martin Rigid Fixation - Sterile is intended to provide, in sterile packaging, osteosynthesis products with the following indications for use:
K051236: The RESORB-X® SF Sonotrode is only intended for use for insertion of the RESORB-X® SF pins.
K032442: The KLS Martin Mandibular/Reconstruction System Il is intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction.
K971297: The KLS Martin Centre-Drive Drill-Free screws are intended for use in rigid internal fixation of the oral-maxillo-cranio-facial bones. The bone screws are used to anchor plates which are contoured to fit the bony surface and stabilize the bone fragments. The addition of the self drilling feature is the only difference between the submitted device and the predicate device reference
K944565: The KLS-Martin Micro Osteosynthesis System is used in oral-maxillo-cranio-facial surgery to stabilize fractured bone segments. The bone segments are attached to the plate with screws to prevent movement of the segments.
K944561: The KLS-Martin Micro Osteosynthesis System is used in oral-maxillo-cranio-facial surgery to stabilize fractured bone segments. The bone segments are attached to the plate with screws to prevent movement of the segments.
KLS Martin Drill-Free MMF Screw (K042573):
The KLS Martin Drill-Free MMF Screws is intended for use in maxillomandibular fixation to provide stabilization of fractures of the maxilla, mandible, or both.
Drill Free MMF Screw (K083432):
The Drill Free MMF Screw is intended for use in maxillomandibular fixation to provide stabilization of fractures of the maxilla, mandible, or both.
KLS Martin L1 MMF System (K173320):
The KLS Martin L1 MMF System is intended for temporary stabilization of mandibular and maxillary fractures. It is designed to maintain proper occlusion during intraoperative bone fixation and postoperative bone healing (app. 6-8 weeks). It is indicated for the temporary treatment of maxillomandibular fixation (MMF) in adults or adolescents who have permanent teeth present (ages 12 and older).
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/K241314 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241314: KLS Martin Oral-Max Implants MR Conditional (bundled).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241314
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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