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RESTORIS

Model 180402 · MAKO SURGICAL CORP. · DI 00848486000400

HRY — Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer · Class II · 21 CFR 888.3530

HSX — Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer · Class II · 21 CFR 888.3520

KRR — Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer · Class II · 21 CFR 888.3540

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

UDILibrary device dossier · generated 2026-09-14 · 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 (2)

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.

Injury: 2

13452019-01: 0 reports for this device; peer average 1.75/device2019-02: 0 reports for this device; peer average 1.73/device2019-03: 0 reports for this device; peer average 1.46/device2019-04: 0 reports for this device; peer average 1.65/device2019-05: 0 reports for this device; peer average 1.64/device2019-06: 0 reports for this device; peer average 1.87/device2019-07: 0 reports for this device; peer average 1.5/device2019-08: 0 reports for this device; peer average 1.51/device2019-09: 0 reports for this device; peer average 1.49/device2019-10: 0 reports for this device; peer average 1.64/device2019-11: 0 reports for this device; peer average 1.27/device2019-12: 0 reports for this device; peer average 2.12/device2020-01: 0 reports for this device; peer average 1.51/device2020-02: 0 reports for this device; peer average 1.88/device2020-03: 0 reports for this device; peer average 2.57/device2020-04: 0 reports for this device; peer average 1.61/device2020-05: 0 reports for this device; peer average 1.35/device2020-06: 0 reports for this device; peer average 3.15/device2020-07: 0 reports for this device; peer average 3.73/device2020-08: 0 reports for this device; peer average 3.67/device2020-09: 0 reports for this device; peer average 3.18/device2020-10: 0 reports for this device; peer average 3.97/device2020-11: 0 reports for this device; peer average 4.15/device2020-12: 0 reports for this device; peer average 5.34/device2021-01: 0 reports for this device; peer average 3.92/device2021-02: 0 reports for this device; peer average 4.53/device2021-03: 0 reports for this device; peer average 2.44/device2021-04: 0 reports for this device; peer average 2.39/device2021-05: 0 reports for this device; peer average 3.75/device2021-06: 0 reports for this device; peer average 4.03/device2021-07: 0 reports for this device; peer average 3.54/device2021-08: 0 reports for this device; peer average 3.54/device2021-09: 0 reports for this device; peer average 4.52/device2021-10: 0 reports for this device; peer average 3.37/device2021-11: 0 reports for this device; peer average 3.36/device2021-12: 0 reports for this device; peer average 3.51/device2022-01: 0 reports for this device; peer average 3.11/device2022-02: 0 reports for this device; peer average 4.21/device2022-03: 0 reports for this device; peer average 3.94/device2022-04: 0 reports for this device; peer average 3.72/device2022-05: 0 reports for this device; peer average 4.68/device2022-06: 0 reports for this device; peer average 3.1/device2022-07: 0 reports for this device; peer average 4.13/device2022-08: 0 reports for this device; peer average 3.02/device2022-09: 0 reports for this device; peer average 3.98/device2022-10: 0 reports for this device; peer average 3.44/device2022-11: 0 reports for this device; peer average 2.88/device2022-12: 0 reports for this device; peer average 3.16/device2023-01: 0 reports for this device; peer average 3.63/device2023-02: 0 reports for this device; peer average 3.1/device2023-03: 0 reports for this device; peer average 2.44/device2023-04: 0 reports for this device; peer average 3.04/device2023-05: 0 reports for this device; peer average 2.89/device2023-06: 0 reports for this device; peer average 3.47/device2023-07: 0 reports for this device; peer average 2.33/device2023-08: 0 reports for this device; peer average 2.24/device2023-09: 0 reports for this device; peer average 1.76/device2023-10: 0 reports for this device; peer average 2.05/device2023-11: 0 reports for this device; peer average 2.58/device2023-12: 0 reports for this device; peer average 1.91/device2024-01: 0 reports for this device; peer average 2.8/device2024-02: 0 reports for this device; peer average 2.15/device2024-03: 0 reports for this device; peer average 2.2/device2024-04: 0 reports for this device; peer average 2.57/device2024-05: 0 reports for this device; peer average 1.87/device2024-06: 0 reports for this device; peer average 2.11/device2024-07: 0 reports for this device; peer average 2.75/device2024-08: 0 reports for this device; peer average 2.1/device2024-09: 0 reports for this device; peer average 2.21/device2024-10: 0 reports for this device; peer average 2.08/device2024-11: 0 reports for this device; peer average 1.95/device2024-12: 0 reports for this device; peer average 2.61/device2025-01: 0 reports for this device; peer average 2.07/device2025-02: 0 reports for this device; peer average 1.91/device2025-03: 0 reports for this device; peer average 1.98/device2025-04: 0 reports for this device; peer average 2.07/device2025-05: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 1.83/device2025-07: 0 reports for this device; peer average 2.32/device2025-08: 0 reports for this device; peer average 1.81/device2025-09: 0 reports for this device; peer average 2.15/device2025-10: 0 reports for this device; peer average 2.21/device2025-11: 0 reports for this device; peer average 1.91/device2025-12: 0 reports for this device; peer average 2.1/device2026-01: 0 reports for this device; peer average 1.71/device2026-02: 0 reports for this device; peer average 2.05/device2026-03: 2 reports for this device; peer average 2.25/device2026-04: 0 reports for this device; peer average 1.85/device2026-05: 0 reports for this device; peer average 2.36/device2026-06: 0 reports for this device; peer average 2.03/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.75
2019-0201.73
2019-0301.46
2019-0401.65
2019-0501.64
2019-0601.87
2019-0701.5
2019-0801.51
2019-0901.49
2019-1001.64
2019-1101.27
2019-1202.12
2020-0101.51
2020-0201.88
2020-0302.57
2020-0401.61
2020-0501.35
2020-0603.15
2020-0703.73
2020-0803.67
2020-0903.18
2020-1003.97
2020-1104.15
2020-1205.34
2021-0103.92
2021-0204.53
2021-0302.44
2021-0402.39
2021-0503.75
2021-0604.03
2021-0703.54
2021-0803.54
2021-0904.52
2021-1003.37
2021-1103.36
2021-1203.51
2022-0103.11
2022-0204.21
2022-0303.94
2022-0403.72
2022-0504.68
2022-0603.1
2022-0704.13
2022-0803.02
2022-0903.98
2022-1003.44
2022-1102.88
2022-1203.16
2023-0103.63
2023-0203.1
2023-0302.44
2023-0403.04
2023-0502.89
2023-0603.47
2023-0702.33
2023-0802.24
2023-0901.76
2023-1002.05
2023-1102.58
2023-1201.91
2024-0102.8
2024-0202.15
2024-0302.2
2024-0402.57
2024-0501.87
2024-0602.11
2024-0702.75
2024-0802.1
2024-0902.21
2024-1002.08
2024-1101.95
2024-1202.61
2025-0102.07
2025-0201.91
2025-0301.98
2025-0402.07
2025-0502
2025-0601.83
2025-0702.32
2025-0801.81
2025-0902.15
2025-1002.21
2025-1101.91
2025-1202.1
2026-0101.71
2026-0202.05
2026-0322.25
2026-0401.85
2026-0502.36
2026-0602.03
This device (reports/month)Average device in HRY, HSX, KRR, NPJ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K082172 — cited as predicate by K133811, K220930, K242831

K090763 — cited as predicate by K133039, K133811, K150410, K160461, K172326, K220930, K242831

K150307 — cites (transitively): K133039 (d1), K090763 (d2) — cited as predicate by K172326, K180612, K220930, K242831

K220930 — cites (transitively): K080368 (d1), K082081 (d1), K082088 (d1), K082172 (d1), K090763 (d1), K150307 (d1), K172326 (d1), K180612 (d1), K133039 (d2), K031729 (d2), K040267 (d2), K042883 (d2), K042993 (d2), K050539 (d2), K051146 (d2), K051380 (d2), K053514 (d2), K061521 (d2), K062037 (d2), K063423 (d2), K070095 (d2), K071881 (d2), K072221 (d2), K072575 (d2), K123166 (d2), K123486 (d2), K132624 (d2), K141056 (d2), K143393 (d2), K172634 (d2), K974556 (d3), K072160 (d3), K051977 (d3), K042067 (d3), K053340 (d3), K100391 (d3), K042871 (d4), K052888 (d4) — cited as predicate by K242831

K242831 — cites (transitively): K031729 (d1), K040267 (d1), K041160 (d1), K042883 (d1), K042993 (d1), K050539 (d1), K051146 (d1), K051380 (d1), K051948 (d1), K052917 (d1), K053514 (d1), K061521 (d1), K062037 (d1), K063423 (d1), K070095 (d1), K071881 (d1), K072221 (d1), K072575 (d1), K082172 (d1), K082567 (d1), K090763 (d1), K123166 (d1), K123486 (d1), K132624 (d1), K141056 (d1), K143393 (d1), K150307 (d1), K172326 (d1), K172634 (d1), K173849 (d1), K180612 (d1), K190402 (d1), K190991 (d1), K200782 (d1), K201343 (d1), K203099 (d1), K210343 (d1), K211303 (d1), K220930 (d1), K230952 (d1), K974556 (d2), K072160 (d2), K051977 (d2), K042067 (d2), K053340 (d2), K100391 (d2), K133039 (d2), K172524 (d2), K173890 (d2), K193515 (d2), K010100 (d2), K020841 (d2), K080368 (d2), K082081 (d2), K082088 (d2), K123907 (d2), K042871 (d3), K052888 (d3), K023546 (d3), K040770 (d3), K060127 (d3), K071413 (d3), K080029 (d3), K113369 (d3), K121771 (d3), K122745 (d3), K122765 (d3), K130143 (d3), K142787 (d3), K121416 (d3), K140826 (d3), K162035 (d3), K191998 (d3), K060370 (d4), K073286 (d4), K933785 (d4), K936159 (d4), K960279 (d4), K081023 (d4), K090968 (d4), K090988 (d4), K102437 (d4), K103170 (d4), K113571 (d4), K972626 (d4), K972770 (d4), K974328 (d4), K991052 (d4), K101433 (d4), K120370 (d4), K062768 (d4), K093746 (d4), K133630 (d4), K170593 (d4), K172219 (d4), K071071 (d5), K962557 (d5), K040166 (d5), K082500 (d5), K943462 (d5), K961685 (d5), K090958 (d5), K951987 (d5), K103662 (d5), K043101 (d5), K141989 (d5), K170581 (d5), K101229 (d6), K121064 (d6), K143752 (d6), K091508 (d7), K093846 (d7), K093425 (d7), K112507 (d7), K022364 (d8), K022365 (d8), K040368 (d8), K050615 (d8), K052213 (d8), K072716 (d8), K091998 (d8), K081867 (d8) — cited as predicate by K252898, K253637

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

Manufacturer compliance record — MAKO SURGICAL CORP.

  • VAI 2018-02-23 Mako Surgical Corporation · 2 citations
  • NAI 2014-11-25 Mako Surgical Corporation · 0 citations
  • VAI 2014-08-11 Mako Surgical Corporation · 3 citations
  • VAI 2013-02-26 Mako Surgical Corporation · 2 citations