This clamp body is the load-bearing casting that holds a 5–8 mm threaded rod or ring-pin against the carbon-fiber ring of an external fixation system (Ilizarov / spatial-frame style). It is investment cast in 17-4PH and heat-treated to H1025 (~ 36 HRC) to balance high fatigue strength and ductility — the clamp must tolerate repeated micro-adjustments over many weeks of external wear without cracking. Each clamp body is CNC machined on all functional faces, then electropolished to remove heat-tint and optimise cleanability. The near-net-shape casting allows complex clamping geometry (multi-axis jaw, set-screw seat, threading boss) to be reproduced consistently across batches of 1,000–20,000 pieces for global orthopedic OEMs. This part is NOT an implantable — it is part of an external fixator assembly that sits outside the body.
Material Specifications
- Standard: 17-4PH (AISI 630 / ASTM A564 Grade 630 / EN 1.4542 / UNS S17400)
- Heat-treat condition: H1025 (≈ 36 HRC, ≥ 1,070 MPa UTS) — chosen for toughness and fatigue performance
- Composition reference: ASTM A564 Type 630; EN 10204 3.1 chemistry certificate
- Bio-compatibility screening: ISO 10993-5 cytotoxicity report available on request
- Magnetic: Low / near-zero after H1025
Dimensional Capability & Tolerance
- Weight range: 25 g – 220 g
- Min. wall thickness: 1.5 mm
- As-cast linear tolerance: ISO 8062 CT5 (≈ ±0.10 mm / 25 mm)
- CNC post-machining: ±0.03 mm on thread seat, clamp jaw, set-screw bore; surface flatness ≤ 0.02 mm
- Clamping force test: each clamp validated to ≥ 1,500 N holding force on calibrated test rig before pack-out
- Inspection: 100% functional test + 100% visual; PPAP-style First Article Inspection Report (FAIR / ISIR) on every new lot
Surface Finish Options
- CNC finished: Ra 0.8 – 1.6 µm on functional faces
- Electropolishing: Ra ≤ 0.4 µm (standard for surgical contact)
- Passivation per ASTM A967: standard
- Black oxide or colour-anodised markings: optional for set-screw identification
Applications
- Ilizarov external ring fixator clamps
- Spatial-frame fixator assemblies (Hexapod / Taylor Spatial Frame compatible geometry)
- External fixator rail clamps
- Adjustable orthopedic braces and frames
- Veterinary orthopedic instruments
Why Choose Ningbo Ruican for This Part
- We understand fatigue-critical orthopedic hardware: 17+ years of stainless steel heat treatment; documented heat-treatment records per lot
- Tightening of UTS / elongation / hardness is verified per heat-treat batch (RP ≥ 1.16 / Rp0.2 ≥ 1,000 MPa typical)
- We support both OEM and contract-manufacturer programs with PPAP / FAIR and full ISO-style documentation
- Drawing-driven: we don’t sell from a catalogue — every fixator clamp is engineered to your STEP / IGES
Certifications & Regulatory Positioning
- IATF 16949 (valid)
- EN 10204 3.1 chemistry and mechanical certificates — supplied per lot
- FAIR / ISIR (PPAP equivalent) and dimensional report per lot
- Project-level ISO 13485 documentation packages supplied on request; Ningbo Ruican is not an ISO 13485 contract manufacturer
