Panels › Orthopedic › Product code JDI · Class 2
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Regulation 888.3350
3510(k)s in 12 months (565 all time)
0recalls in 12 months (255 all time)
161recalls that name a 510(k)
Top companies in JDI
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer Biomet | 1 | 92 |
| Biomet, Inc. | 51 | 18 |
| Zimmer, Inc. | 27 | 23 |
| Depuy, Inc. | 45 | 0 |
| Howmedica Corp. | 43 | 0 |
| Stryker Howmedica Osteonics | 0 | 37 |
| DePuy Orthopaedics, Inc. | 12 | 20 |
| Osteonics Corp. | 29 | 0 |
| Howmedica Osteonics | 17 | 11 |
| Intermedics Orthopedics | 21 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2025 | BioPro, Inc. BioPro Femoral Head
Product ID/Description
14089 HEAD FEMORAL 28 SH LT
14090 HEAD FEMORAL 28 MD LT
14091 HEAD FEMORAL 28 LG LT
14094 HEAD FEMORAL 32 SH LT
14095 HEAD FEMORAL 32 MD LT
14096 HEAD FEMO Open, Classified |
JDI | K872856 |
| Sep 26, 2025 | Howmedica Osteonics Corp. 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442;
2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352; Open, Classified |
JDI | K193429 |
| Aug 25, 2025 | Onkos Surgical, Inc. ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants. Open, Classified |
JDI | K161520 K203588 |
| Aug 25, 2025 | Onkos Surgical, Inc. ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants. Open, Classified |
JDI | K161520 K203588 |
| Aug 25, 2025 | Onkos Surgical, Inc. ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants. Open, Classified |
JDI | K161520 K203588 |
| May 29, 2025 | Onkos Surgical, Inc. Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M.
Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM Open, Classified |
JDI | K203815 |
| May 23, 2025 | Onkos Surgical, Inc. ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M.
Component of Limb Salvage System with BioGrip. Open, Classified |
JDI | K203815 |
| May 23, 2025 | Onkos Surgical, Inc. ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M.
Component of Limb Salvage System with BioGrip. Open, Classified |
JDI | K203815 |
| Aug 26, 2024 | Howmedica Osteonics Corp. Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00; Open, Classified |
JDI | K023087 K222056 |
| Jul 30, 2024 | Zimmer, Inc. CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000
00811400010
00811400100
00811400110
00811400200
00811400210
00811400218
00811400230 Open, Classified |
JDI | K960658 |
| Jun 25, 2024 | Biomet, Inc. RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty
Item Number: 11-165206 Open, Classified |
JDI | K051569 |
| Sep 7, 2023 | Zimmer, Inc. M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440) Open, Classified |
JDI | K200823 |
| Aug 11, 2022 | Exactech, Inc. GXL acetabular liners, orthopedic hip implant component. Product Line Numbers:
a. ACUMATCH 0 DEGREE LINER 28MM 46MM, REF 130-28-05;
b. ACUMATCH 0 DEGREE LINER 28MM 48MM, REF 130-28-06;
c. ACUMATC Open, Classified |
JDI | K993082 |
| Aug 11, 2022 | Exactech, Inc. GXL acetabular liners, orthopedic hip implant component. Product Line Numbers:
a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42;
b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTE Open, Classified |
JDI | K963313 |
| Jul 22, 2022 | Corin Ltd Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103 Open, Classified |
JDI | K082525 K153381 |
| Jul 12, 2022 | Corin Ltd TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component. Terminated |
JDI | K142761 |
| May 4, 2022 | MicroPort Orthopedics Inc. PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK Terminated |
JDI | K123434 |
| May 7, 2021 | DePuy Orthopaedics, Inc. DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis.
Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR Terminated |
JDI | K843909 |
| Dec 17, 2020 | Biomet, Inc. OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in limb salvage. Terminated |
JDI | K002757 |
| Oct 9, 2020 | Biomet, Inc. (1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom:
Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM:
Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) Terminated |
JDI | K051569 |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 61 mm
Number: 00-8065-958-32 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 59 mm
Number: 00-8065-956-32 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 57 mm
Number: 00-8065-954-32 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 55 mm
Number: 00-8065-952-32 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 53 mm
Number: 00-8065-950-32 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 51mm
Number: 00-8065-948-32 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 49 mm
Number: 00-8065-946-32 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm
Number: 00-8065-658-32 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm
Number: 00-8065-658-28 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm
Number: 00-8065-658-26 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm
Number: 00-8065-658-22 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 59 mm
Number: 00-8065-656-32 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 59 mm
Number: 00-8065-656-28 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 59 mm
Number: 00-8065-656-26 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 59 mm
Number: 00-8065-656-22 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm
Number: 00-8065-654-32 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm
Number: 00-8065-654-28 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm
Number: 00-8065-654-26 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm
Number: 00-8065-654-22 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm
Number: 00-8065-652-32 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm
Number: 00-8065-652-28 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm
Number: 00-8065-652-26 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm
Number: 00-8065-652-22 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm
Number: 00-8065-650-32 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm
Number: 00-8065-650-28 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm
Number: 00-8065-650-26 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm
Number: 00-8065-650-22 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm
Number: 00-8065-648-32 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm
Number: 00-8065-648-28 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm
Number: 00-8065-648-26 Terminated |
JDI | None listed |
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