510(k) · Cleared
ClearedKLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KLS-Martin L.P. · GXN Plate, Cranioplasty, Preformed, Non-Alterable
Cleared on Nov 10, 2025 as substantially equivalent to K944565 (KLS-Martin L.P., 1994) and 5 other predicates after an 88-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Nov 10, 2025
- Review
- 88 days
- Class
- Class II
- Product code
- GXN
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 7 generations to K904436 (1990). 53 ancestors in all, the oldest K832283 (1984). No later device cites it as a predicate yet.
- 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 deviceK252573 KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin…KLS-Martin L.P. · 2025
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) | K252573 | KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro… | KLS-Martin L.P. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 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 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2015 | 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 GXN? 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 GXN device
- #1 K260709 ClearFit Ti Ring 14mm (171750);ClearFit Ti…score 13.7 · 8 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 |
|---|---|---|---|
| * | K944565 | KLS-Martin Micro Osteosythesis System (1.5MM)Summary page 6…ass: II Primary Product Code: GXN Associated Product Codes: JEY, HRS, GXP Predicate Devices: KLS-Martin Micro Osteosynthesis System (K944565) KLS Martin Centre-Drive Drill-Free Screw (K971297) KLS Martin Ri… | 1994 |
| * | K971297 | Centre-Drive Drill-Free ScrewSummary page 6…JEY, HRS, GXP Predicate Devices: KLS-Martin Micro Osteosynthesis System (K944565) KLS Martin Centre-Drive Drill-Free Screw (K971297) KLS Martin Rigid Fixation – Sterile (K060177) Individual Patient… | 1997 |
| * | K060177 | KLS Martin Rigid Fixation - SterileSummary page 6…System (K944565) KLS Martin Centre-Drive Drill-Free Screw (K971297) KLS Martin Rigid Fixation – Sterile (K060177) Individual Patient Solutions – Ti (IPS-Ti) (K062570) Individual… | 2006 |
| * | K062570 | Patient Contoured Mesh (PCM)Summary page 6…Screw (K971297) KLS Martin Rigid Fixation – Sterile (K060177) Individual Patient Solutions – Ti (IPS-Ti) (K062570) Individual Patient Solutions - PEEK (IPS-PEEK) (K072707) Individ… | 2006 |
| * | K072707 | Patient Contoured Mesh-Peek (PCM-P)Summary page 6…177) Individual Patient Solutions – Ti (IPS-Ti) (K062570) Individual Patient Solutions - PEEK (IPS-PEEK) (K072707) Individual Patient Solutions - (IPS-PEEK) (K151382) Reference Device: Not applicab… | 2007 |
| * | K151382 | Patient Contoured Implant-PEEK (PCI-PEEK)Summary page 6…2570) Individual Patient Solutions - PEEK (IPS-PEEK) (K072707) Individual Patient Solutions - (IPS-PEEK) (K151382) Reference Device: Not applicable to this bundled 510(k) submission Device Description: KLS-Martin Micro Osteosynth… | 2015 |
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 35 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 53 ancestors have a recall of any class.
- 14 other devices also cite its predicate K944565.
How does its category compare?
All GXN devicesGXN Plate, Cranioplasty, Preformed, Non-Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · GXN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXN
69in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXN
6in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXN
24in 2025
MAUDE reports naming product code GXN, 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 | 2 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 17 |
| 2009 | 0 | — | 0 | 17 |
| 2010 | 0 | — | 0 | 23 |
| 2011 | 2 | — | 0 | 20 |
| 2012 | 3 | 102 | 0 | 29 |
| 2013 | 1 | — | 0 | 57 |
| 2014 | 2 | — | 0 | 60 |
| 2015 | 2 | — | 0 | 47 |
| 2016 | 1 | — | 0 | 35 |
| 2017 | 2 | — | 0 | 74 |
| 2018 | 3 | 199 | 6 | 56 |
| 2019 | 0 | — | 0 | 54 |
| 2020 | 5 | 33 | 0 | 63 |
| 2021 | 3 | 69 | 0 | 63 |
| 2022 | 2 | — | 0 | 57 |
| 2023 | 1 | — | 0 | 32 |
| 2024 | 1 | — | 0 | 35 |
| 2025 | 2 | — | 0 | 24 |
| 2026 | 4 | 193 | 0 | — |
What is it indicated for?
KLS-Martin Micro Osteosynthesis System (1.5MM): 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: The KLS Martin Centre-Drive Drill-Free Screws are intended for use in rigid internal fixation of the oral-maxillo-cranio-facial bones. The…
Read the full statement (357 words)
KLS-Martin Micro Osteosynthesis System (1.5MM):
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:
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 Rigid Fixation - Sterile:
The KLS Martin Rigid Fixation - Sterile is intended to provide, in sterile packaging, osteosynthesis products with the following indications for use:
-The RESORB-X® SF Sonotrode is only intended for use for insertion of the RESORB-X® SF pins.
-The KLS Martin Mandibular/Reconstruction System II is intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction.
-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
-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.
-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.
Individual Patient Solutions - Ti (IPS-Ti)*:
Individual Patient Solutions - Ti (IPS-Ti) is intended to replace bony voids in the mandibular, maxillofacial or craniofacial skeleton.
Individual Patient Solutions - PEEK (IPS-PEEK)*:
Individual Patient Solutions - PEEK (IPS-PEEK) is intended to replace bony voids in the cranial and/or craniofacial skeleton.
Individual Patient Solutions - (IPS-PEEK)**:
The Individual Patient Solutions - (IPS-PEEK) is intended to replace bony voids in the cranial skeleton.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252573 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252573: KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252573
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