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DJO SURGICAL

Model 355-02-002 · Encore Medical, L.P. · DI 00190446844495

JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer · Class II · 21 CFR 888.3560

MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer · Class II · 21 CFR 888.3565

UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

11232019-01: 0 reports for this device; peer average 1.9/device2019-02: 0 reports for this device; peer average 1.96/device2019-03: 0 reports for this device; peer average 1.62/device2019-04: 0 reports for this device; peer average 1.9/device2019-05: 0 reports for this device; peer average 1.74/device2019-06: 0 reports for this device; peer average 2.03/device2019-07: 0 reports for this device; peer average 1.94/device2019-08: 0 reports for this device; peer average 2.11/device2019-09: 0 reports for this device; peer average 1.86/device2019-10: 0 reports for this device; peer average 2.21/device2019-11: 0 reports for this device; peer average 2.73/device2019-12: 0 reports for this device; peer average 2.22/device2020-01: 0 reports for this device; peer average 2.22/device2020-02: 0 reports for this device; peer average 2.55/device2020-03: 0 reports for this device; peer average 2.11/device2020-04: 0 reports for this device; peer average 2.02/device2020-05: 0 reports for this device; peer average 1.71/device2020-06: 0 reports for this device; peer average 1.96/device2020-07: 0 reports for this device; peer average 2.49/device2020-08: 0 reports for this device; peer average 2.54/device2020-09: 0 reports for this device; peer average 2.1/device2020-10: 0 reports for this device; peer average 2.65/device2020-11: 0 reports for this device; peer average 2.59/device2020-12: 0 reports for this device; peer average 2.69/device2021-01: 0 reports for this device; peer average 2.25/device2021-02: 0 reports for this device; peer average 2.24/device2021-03: 0 reports for this device; peer average 2.39/device2021-04: 0 reports for this device; peer average 2.21/device2021-05: 0 reports for this device; peer average 2.16/device2021-06: 0 reports for this device; peer average 2.05/device2021-07: 0 reports for this device; peer average 2.04/device2021-08: 0 reports for this device; peer average 1.75/device2021-09: 0 reports for this device; peer average 2.13/device2021-10: 0 reports for this device; peer average 1.81/device2021-11: 0 reports for this device; peer average 2.1/device2021-12: 0 reports for this device; peer average 2.16/device2022-01: 0 reports for this device; peer average 1.87/device2022-02: 0 reports for this device; peer average 2.2/device2022-03: 0 reports for this device; peer average 1.87/device2022-04: 0 reports for this device; peer average 1.93/device2022-05: 0 reports for this device; peer average 2.11/device2022-06: 0 reports for this device; peer average 1.87/device2022-07: 0 reports for this device; peer average 1.92/device2022-08: 0 reports for this device; peer average 1.94/device2022-09: 0 reports for this device; peer average 2.07/device2022-10: 0 reports for this device; peer average 2.04/device2022-11: 0 reports for this device; peer average 2.1/device2022-12: 0 reports for this device; peer average 1.77/device2023-01: 0 reports for this device; peer average 1.92/device2023-02: 0 reports for this device; peer average 2.05/device2023-03: 0 reports for this device; peer average 2.04/device2023-04: 0 reports for this device; peer average 2.1/device2023-05: 0 reports for this device; peer average 2.22/device2023-06: 0 reports for this device; peer average 2.1/device2023-07: 0 reports for this device; peer average 1.87/device2023-08: 0 reports for this device; peer average 1.59/device2023-09: 0 reports for this device; peer average 1.64/device2023-10: 0 reports for this device; peer average 1.53/device2023-11: 0 reports for this device; peer average 1.59/device2023-12: 0 reports for this device; peer average 1.59/device2024-01: 0 reports for this device; peer average 1.47/device2024-02: 0 reports for this device; peer average 1.63/device2024-03: 0 reports for this device; peer average 1.68/device2024-04: 0 reports for this device; peer average 1.56/device2024-05: 0 reports for this device; peer average 1.76/device2024-06: 0 reports for this device; peer average 1.84/device2024-07: 0 reports for this device; peer average 1.7/device2024-08: 0 reports for this device; peer average 2.16/device2024-09: 0 reports for this device; peer average 1.85/device2024-10: 0 reports for this device; peer average 1.85/device2024-11: 0 reports for this device; peer average 1.81/device2024-12: 0 reports for this device; peer average 1.92/device2025-01: 0 reports for this device; peer average 2.12/device2025-02: 0 reports for this device; peer average 1.71/device2025-03: 0 reports for this device; peer average 1.69/device2025-04: 0 reports for this device; peer average 1.56/device2025-05: 0 reports for this device; peer average 1.61/device2025-06: 0 reports for this device; peer average 1.68/device2025-07: 0 reports for this device; peer average 1.53/device2025-08: 0 reports for this device; peer average 1.56/device2025-09: 0 reports for this device; peer average 1.53/device2025-10: 0 reports for this device; peer average 1.38/device2025-11: 0 reports for this device; peer average 1.58/device2025-12: 0 reports for this device; peer average 1.57/device2026-01: 0 reports for this device; peer average 1.47/device2026-02: 0 reports for this device; peer average 1.46/device2026-03: 0 reports for this device; peer average 1.81/device2026-04: 0 reports for this device; peer average 1.62/device2026-05: 0 reports for this device; peer average 1.59/device2026-06: 0 reports for this device; peer average 1.57/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.9
2019-0201.96
2019-0301.62
2019-0401.9
2019-0501.74
2019-0602.03
2019-0701.94
2019-0802.11
2019-0901.86
2019-1002.21
2019-1102.73
2019-1202.22
2020-0102.22
2020-0202.55
2020-0302.11
2020-0402.02
2020-0501.71
2020-0601.96
2020-0702.49
2020-0802.54
2020-0902.1
2020-1002.65
2020-1102.59
2020-1202.69
2021-0102.25
2021-0202.24
2021-0302.39
2021-0402.21
2021-0502.16
2021-0602.05
2021-0702.04
2021-0801.75
2021-0902.13
2021-1001.81
2021-1102.1
2021-1202.16
2022-0101.87
2022-0202.2
2022-0301.87
2022-0401.93
2022-0502.11
2022-0601.87
2022-0701.92
2022-0801.94
2022-0902.07
2022-1002.04
2022-1102.1
2022-1201.77
2023-0101.92
2023-0202.05
2023-0302.04
2023-0402.1
2023-0502.22
2023-0602.1
2023-0701.87
2023-0801.59
2023-0901.64
2023-1001.53
2023-1101.59
2023-1201.59
2024-0101.47
2024-0201.63
2024-0301.68
2024-0401.56
2024-0501.76
2024-0601.84
2024-0701.7
2024-0802.16
2024-0901.85
2024-1001.85
2024-1101.81
2024-1201.92
2025-0102.12
2025-0201.71
2025-0301.69
2025-0401.56
2025-0501.61
2025-0601.68
2025-0701.53
2025-0801.56
2025-0901.53
2025-1001.38
2025-1101.58
2025-1201.57
2026-0101.47
2026-0201.46
2026-0301.81
2026-0401.62
2026-0501.59
2026-0601.57
This device (reports/month)Average device in JWH, MBH (reports/device/month)

Regulatory clearances

  • K240324 SESE 2024-04-26 (k number procode)

Predicate lineage

K240324 — cites (transitively): K072888 (d1), K160342 (d1), K173723 (d1), K200075 (d1), K200653 (d1), K201364 (d1), K213793 (d1), K230441 (d1), K100900 (d2), K121727 (d2), K143242 (d2), K933539 (d2), K932425 (d2), K103517 (d2), K170149 (d2), K053340 (d2), K102896 (d2), K141934 (d2), K143393 (d2), K151266 (d2), K152008 (d2), K143179 (d2), K151008 (d2), K152431 (d2), K200113 (d2), K140830 (d2), K030686 (d3), K905613 (d3), K923277 (d3), K932690 (d3), K932776 (d3), K933494 (d3), K040487 (d3), K040630 (d3), K098078 (d3), K982302 (d3), K091956 (d3), K033260 (d3), K093552 (d3), K121443 (d3), K951987 (d3), K013385 (d3), K020114 (d3), K100391 (d3), K123486 (d3), K132624 (d3), K023087 (d3), K142187 (d3), K113550 (d3), K974556 (d3), K042515 (d3), K121879 (d3), K072336 (d3), K090988 (d3), K102437 (d3), K130299 (d3), K141395 (d3), K153595 (d3), K032905 (d4), K080528 (d4), K042871 (d4), K052888 (d4), K033489 (d4), K050222 (d4), K060303 (d4), K101499 (d4), K111711 (d4), K113482 (d4), K101281 (d4), K072160 (d4), K002552 (d4), K896048 (d4), K031729 (d4), K040267 (d4), K042883 (d4), K042993 (d4), K051146 (d4), K051380 (d4), K051977 (d4), K053514 (d4), K061521 (d4), K072221 (d4), K072575 (d4), K123166 (d4), K955296 (d4), K102975 (d4), K023211 (d5), K041825 (d5), K062654 (d5), K070479 (d5), K032295 (d5), K071071 (d5), K073325 (d5), K022204 (d5), K051229 (d5), K946236 (d5), K050539 (d5), K063423 (d5) — cited as predicate by K251241

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Encore Medical, L.P.

  • VAI 2021-10-28 Encore Medical, LP · 2 citations
  • NAI 2020-03-11 Encore Medical, LP · 0 citations
  • NAI 2015-07-24 Encore Medical, LP · 0 citations
  • VAI 2013-06-28 Encore Medical, LP · 2 citations