FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KLS Martin Pure Pectus System
K Number: K253660
·
Decision Feb 20, 2026
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
58
Review Days
92
Basic Information
- Device Name
- KLS Martin Pure Pectus System
- K Number
- K253660
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- KLS-Martin L.P.
- Date Received
- November 20, 2025
- Decision Date
- February 20, 2026
- Product Code
- HRS
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L
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Other Clearances by KLS-Martin L.P.
| K Number | Device Name | ||
|---|---|---|---|
| K250988 | KLS Martin Pure Pectus System | Dec 11, 2025 | Substantially Equivalent |
| K250865 | KLS Martin IPS Forearm System | Nov 14, 2025 | Substantially Equivalent |
| 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 | Nov 10, 2025 | Substantially Equivalent |
| K233721 | KLS Martin Drill-Free MMF Screw | Sep 17, 2024 | Substantially Equivalent |
| K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled) | Aug 16, 2024 | Substantially Equivalent |
| K241018 | KLS Martin Orthopedic Implants - MR Conditional | Jul 12, 2024 | Substantially Equivalent |
| K230211 | CranioXpand | Nov 21, 2023 | Substantially Equivalent |
| K222624 | KLS Martin LINOS Wrist System | May 25, 2023 | Substantially Equivalent |
| K222397 | KLS Martin Level One Rib Fixation System | Mar 29, 2023 | Substantially Equivalent |
| K210731 | KLS Martin Individual Patient Solutions | Jul 18, 2022 | Substantially Equivalent |