Signature Orthopaedics PTY Limited (manufacturer, Sydney New South Wales, AU): 12 new FDA device listings, incl. prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Signature Orthopaedics PTY Limited (Sydney New South Wales): 12 new FDA device listings, incl. prosthesis, hip, semi-constrained, metal/polymer, porous uncemented. Its amount of 12 is top-decile (94th percentile of 2,709 records). Dated 121 days ago, it serves as a historical benchmark. Score 75/100. As of 2026-11-04, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 12 · 94th percentile of 2,709 DeviceEstablishmentPulse records · 6.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 24 related AU DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Signature Orthopaedics PTY Limited |
| Owner / operator | Signature Orthopaedics Pty Limited |
| Role | Manufacturer |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device |
| Location | Sydney New South Wales, AU |
| New listings | 12 |
| Devices | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component); Prosthesis, Hip, Femoral, Resurfacing |
| Product codes | LPH, KWY, LZO, KWZ, JDI, MEH, KWA, KXA |
| Device classes | Class II, Class III |
| Medical specialties | Orthopedic |
| Brand names | Evolve AP Cup |
| First new listing | 2026-06-01 |
| Latest new listing | 2026-07-07 |
| FDA registration number | 3008262872 |
| Registration expires | 2026-12-31 |
| amount percentile | 94th of 2,709 (median 2, 6.0x median) |
| Peer records CSV (25 AU records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-07-07
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (AU first): Makar Consulting PTY Ltd (foreign exporter, Belrose New Sout · Kico Knee Innovation Company (manufacturer, Frenchs Forest N · Precision Ai PTY Ltd (contract manufacturer, Brisbane Queens · Merit Medical Australia Pty Ltd. (foreign exporter, Braiside · EvERX PTY LTD (foreign exporter, Sydney New South Wales, AU) · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT
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Peer benchmark and outreach value: Signature Orthopaedics PTY Limited and 25 AU peers
- AU DeviceEstablishmentPulse records like this one: 25
- Signature Orthopaedics PTY Limited's amount: 94th percentile of 2,709 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every AU peer: $5,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
75 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
What is the DeviceEstablishmentPulse record for Signature Orthopaedics PTY Limited in Sydney New South Wales?
Signature Orthopaedics PTY Limited (Sydney New South Wales, AU), a manufacturer, added 12 FDA device listings between 2026-06-01 and 2026-07-07.
How does Signature Orthopaedics PTY Limited compare to other DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 12 is 6.0x the median of 2 across 2,709 records. It is 121 days old; check the official source for later updates before acting. Its Score of 75/100 puts it among the stronger signals in this feed.
Signature Orthopaedics PTY Limited vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Signature Orthopaedics PTY Limited | Sydney New South Wales, AU | 12 | 94th | 2026-07-07 |
| Biomerieux, Inc. | Hazelwood, MO | 12 | 94th | 2026-10-22 |
| Intuitive Surgical, Inc. | Sunnyvale, CA | 13 | 95th | 2026-10-22 |
| Intuitive Surgical, Inc. | Santa Clara, CA | 13 | 95th | 2026-10-22 |
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DeviceEstablishmentPulse: Manufacturer DeviceEstablishmentPulse: Foreign establishment
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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.