| Primary Device ID | 00816127029011 |
| NIH Device Record Key | 3d842789-9aed-45a6-8cb7-746c2fa3b56d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iNSitu Total Hip System |
| Version Model Number | 10-10-0012-TC |
| Company DUNS | 060211165 |
| Company Name | NEXTSTEP ARTHROPEDIX, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816127029011 [Primary] |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00816127029011]
Ethylene Oxide
[00816127029011]
Ethylene Oxide
[00816127029011]
Ethylene Oxide
[00816127029011]
Ethylene Oxide
[00816127029011]
Ethylene Oxide
[00816127029011]
Ethylene Oxide
[00816127029011]
Ethylene Oxide
[00816127029011]
Ethylene Oxide
[00816127029011]
Ethylene Oxide
[00816127029011]
Ethylene Oxide
[00816127029011]
Ethylene Oxide
[00816127029011]
Ethylene Oxide
[00816127029011]
Ethylene Oxide
[00816127029011]
Ethylene Oxide
[00816127029011]
Ethylene Oxide
[00816127029011]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-16 |
| Device Publish Date | 2024-08-08 |
| 00816127029189 | Femoral Stem, Size 14, Lateral, Taper Coated |
| 00816127029172 | Femoral Stem, Size 13, Lateral, Taper Coated |
| 00816127029165 | Femoral Stem, Size 12, Lateral, Taper Coated |
| 00816127029158 | Femoral Stem, Size 11, Lateral, Taper Coated |
| 00816127029141 | Femoral Stem, Size 10, Lateral, Taper Coated |
| 00816127029134 | Femoral Stem, Size 9, Lateral, Taper Coated |
| 00816127029127 | Femoral Stem, Size 8, Lateral, Taper Coated |
| 00816127029110 | Femoral Stem, Size 7, Lateral, Taper Coated |
| 00816127029103 | Femoral Stem, Size 6, Lateral, Taper Coated |
| 00816127029097 | Femoral Stem, Size 5, Lateral, Taper Coated |
| 00816127029080 | Femoral Stem, Size 4, Lateral, Taper Coated |
| 00816127029073 | Femoral Stem, Size 3, Lateral, Taper Coated |
| 00816127029066 | Femoral Stem, Size 2, Lateral, Taper Coated |
| 00816127029059 | Femoral Stem, Size 1, Lateral, Taper Coated |
| 00816127029042 | Femoral Stem, Size 0, Lateral, Taper Coated |
| 00816127029035 | Femoral Stem, Size 14, Standard, Taper Coated |
| 00816127029028 | Femoral Stem, Size 13, Standard, Taper Coated |
| 00816127029011 | Femoral Stem, Size 12, Standard, Taper Coated |
| 00816127029004 | Femoral Stem, Size 11, Standard, Taper Coated |
| 00816127028991 | Femoral Stem, Size 10, Standard, Taper Coated |
| 00816127028984 | Femoral Stem, Size 9, Standard, Taper Coated |
| 00816127028977 | Femoral Stem, Size 8, Standard, Taper Coated |
| 00816127028960 | Femoral Stem, Size 7, Standard, Taper Coated |
| 00816127028953 | Femoral Stem, Size 6, Standard, Taper Coated |
| 00816127028946 | Femoral Stem, Size 5, Standard, Taper Coated |
| 00816127028939 | Femoral Stem, Size 4, Standard, Taper Coated |
| 00816127028922 | Femoral Stem, Size 3, Standard, Taper Coated |
| 00816127028915 | Femoral Stem, Size 2, Standard, Taper Coated |
| 00816127028908 | Femoral Stem, Size 1, Standard, Taper Coated |
| 00816127028892 | Femoral Stem, Size 0, Standard, Taper Coated |
| 00816127025082 | Lateralized Liner Trial Size 62/68 x 40mm ID |
| 00816127025075 | Lateralized Liner Trial Size 58/60 x 40mm ID |
| 00816127025068 | Lateralized Liner Trial Size 54/56 x 40mm ID |
| 00816127025051 | Lateralized Liner Trial Size 62/68 x 36mm ID |
| 00816127025044 | Lateralized Liner Trial Size 58/60 x 36mm ID |
| 00816127025037 | Lateralized Liner Trial Size 54/56 x 36mm ID |
| 00816127025020 | Lateralized Liner Trial Size 52 x 36mm ID |
| 00816127025013 | Lateralized Liner Trial Size 50 x 36mm ID |
| 00816127025006 | Lateralized Liner Trial Size 48 x 32mm ID |
| 00816127024993 | Lateralized Liner Trial Size 46 x 32mm ID |
| 00816127024986 | Lateralized Liner Trial Size 42/44 x 28mm ID |
| 00816127024924 | Cemented Femoral Stem, Size 14, Lateralized |
| 00816127024917 | Cemented Femoral Stem, Size 13, Lateralized |
| 00816127024900 | Cemented Femoral Stem, Size 12, Lateralized |
| 00816127024894 | Cemented Femoral Stem, Size 11, Lateralized |
| 00816127024887 | Cemented Femoral Stem, Size 10, Lateralized |
| 00816127024870 | Cemented Femoral Stem, Size 9, Lateralized |
| 00816127024863 | Cemented Femoral Stem, Size 8, Lateralized |
| 00816127024856 | Cemented Femoral Stem, Size 7, Lateralized |
| 00816127024849 | Cemented Femoral Stem, Size 6, Lateralized |