510(k) · Cleared
ClearedKLS Martin Rigid Fixation - Sterile
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 Apr 18, 2006 as substantially equivalent to K032442 (KLS-Martin L.P., 2003) and 4 other predicates after an 85-day review. Its family tree reaches back 6 generations to 1990. 65 later devices descend from it.
- Decided
- Apr 18, 2006
- Review
- 85 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K904436 (1990). 42 ancestors in all, the oldest K900138 (1990). 65 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 5 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 4 generations backK972783 Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc. · 1998
- 3 generations backK982139 Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998
- 2 generations backK993061 Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999
- 1 generation backK011590 Resorb-X Resorbable Plating SystemKLS-Martin L.P. · 2002
- This deviceK060177 KLS Martin Rigid Fixation - SterileKLS Martin L.P. · 2006
- Descendant · cites it directly · 61 of its ownK070169 KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007
- Descendant · 2 generations on · 45 of its ownK151983 KLS Martin LSS Plating SystemKLS Martin L.P. · 2016
- Descendant · 3 generations on · 39 of its ownK202889 Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021
- Descendant · 4 generations on · 36 of its ownK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022
- Descendant · 5 generations on · 28 of its ownK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 65 · See all- K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007 · cites it directly61descendants
- K151983KLS Martin LSS Plating SystemKLS Martin L.P. · 2016 · 2 generations on45descendants
- K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021 · 3 generations on39descendants
- K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc. · 2022 · 4 generations on36descendants
- K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine · 2022 · 5 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −5 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −4 | K972783 | Biofix Biodegradable Threaded Suture Anchor | Bionx Implants, Inc. | 1998 | — |
| −3 | K982139 | Biosorbfx 1.5/2.0 Bioabsorbable Fixation System | Bionx Implants, Inc. | 1998 | — |
| −2 | K993061 | Stryker Leibinger Resorbable Fixation System | Stryker Instruments | 1999 | — |
| −1 | K011590 | Resorb-X Resorbable Plating System | KLS-Martin L.P. | 2002 | — |
| 0 (this device) | K060177 | KLS Martin Rigid Fixation - Sterile | KLS Martin L.P. | 2006 | — |
| +1 | K070169 | KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile | KLS Martin L.P. | 2007 | — |
| +2 | K151983 | KLS Martin LSS Plating System | KLS Martin L.P. | 2016 | — |
| +3 | K202889 | Able Medical Devices Valkyrie Thoracic Fixation System | Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices | 2021 | — |
| +4 | K220782 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine, Inc. | 2022 | — |
| +5 | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1996 | 7 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 8 | 0 |
| 2024 | 13 | 0 |
| 2025 | 15 | 0 |
| 2026 | 12 | 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? (5)
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 |
|---|---|---|---|
| * | K032442 | KLS-Martin Mandibular/Reconstruction System IISummary page 1…on Name and Number: Bone Plate (CFR 872.4760) Regulatory Class: 1I Predicate Devices: KLS-Martin Mandibular/Reconstruction System 11 (K032442) Resorb-X Resorbable Plating System (KO1 1590) Centre-Drive Drill-Free Screw (K971297)… | 2003 |
| * | K011590 | Resorb-X Resorbable Plating System | 2002 |
| * | K971297 | Centre-Drive Drill-Free ScrewSummary page 1…ction System 11 (K032442) Resorb-X Resorbable Plating System (KO1 1590) Centre-Drive Drill-Free Screw (K971297) Micro Osteosynthesis System (1.0) (K944561) KILS-Martin Micro Osteosythesis System (1.… | 1997 |
| * | K944561 | Micro Osteosynthesis System (1.0)Summary page 1…Resorb-X Resorbable Plating System (KO1 1590) Centre-Drive Drill-Free Screw (K971297) Micro Osteosynthesis System (1.0) (K944561) KILS-Martin Micro Osteosythesis System (1.5mm) (K944565) Device Description: T… | 1994 |
| * | K944565 | KLS-Martin Micro Osteosythesis System (1.5MM)Summary page 1…crew (K971297) Micro Osteosynthesis System (1.0) (K944561) KILS-Martin Micro Osteosythesis System (1.5mm) (K944565) Device Description: The KLS Martin Rigid Fixation - Sterile includes titanium plates of various sha… | 1994 |
What descends from it? (65)
See all 653 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)
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 16 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 42 ancestors have a recall of any class.
- Of its descendants, K070169 (KLS Martin L.P., 2007) has gone furthest, with 61 descendants of its own.
- 6 other devices also cite its predicate K032442.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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-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 IIis intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction. K971297: The KLS Martin Centre-Drive…
Read the full statement (182 words)
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 IIis 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 structures 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 cral-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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060177 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060177: KLS Martin Rigid Fixation - Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060177
Report an extraction error
Are you the manufacturer?
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